A Phase 2 interventional study of RS-113, 160 mg and RS-113, 240 mg in Metastatic Castration-resistant Prostate Cancer, sponsored by R-Pharm International, LLC. Active, not recruiting at 16 sites in Russia. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by R-Pharm International, LLC (part of R-Pharm) · Phase 2, Interventional, and Treatment
The primary objective of the study is to determine the therapeutic dose of RS-113 in patients with metastatic castration-resistant prostate cancer based on efficacy, safety, and pharmacokinetic parameters. The secondary objectives are to assess a pilot efficacy and safety of different doses of RS-113 versus abiraterone, as well as to investigate pharmacokinetics profile and to perform a pilot evaluation of pharmacokinetics parameters of RS-113 in patients with metastatic castration-resistant prostate cancer
This is an open-label, randomized, comparative phase II clinical trial conducted in 4 treatment arms:
All enrolled patients who have not previously undergone a surgical castration will receive androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) analogues throughout the study
The study will include the following periods:
Core study: up to 2 years Days [1 to 728]
Eligible patients should be randomized to one of four treatment arms (in a 1:1:1:1 ratio):
During the core study, the treatment will continue until the earliest of the following:
During the core study tumor response assessments will be performed approximately every 8 weeks for the first 24 weeks, and every 12 weeks thereafter
Extension phase
Patients who had stable disease or tumor response within 2 years of treatment may be enrolled in an extension study. During the Extension phase, patients will continue to receive the same treatment regimen as assigned in the Core study
During the Extension phase, the treatment will be administered from Day 728 until the earliest of the following:
Follow-up period (follow-up/FU)
Completing the last visit means the end of participation in the clinical trial for each particular patient
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →R-Pharm International, LLC is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Evidence of progressive disease at the time of randomization, defined by one or more of the following criteria:
Major organ function must meet the following criteria:
Exclusion Criteria:
Prior antitumor therapy:
cardiovascular disease, including:
Clinically significant CNS disorders, including:
Prior or concomitant therapy:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RS-113 is taken once daily (QD) orally, 2 capsules at a time (160 mg), 1 hour after a meal in the morning Androgen deprivation therapy (ADT) will be administered using analogues of luteinizing hormone-releasing hormone (aLHRH): * goserelin (at a dose of 3.6mg every 28 days or 10.8 mg every 84 days, subcutaneously, into the anterior abdominal wall), or * leuprorelin (7.5 mg every 28 days or 22.5 mg every 3 months, subcutaneously, into the anterior abdominal wall), or * triptorelin (3.75 mg every 28 days intramuscularly), or * buserelin (3.75 mg every 28 days, intramuscularly)
Drug: RS-113, 160 mg · Drug: Androgen deprivation therapy (ADT)
RS-113 is taken orally QD, 3 capsules at a time (240 mg), 1 hour after a meal in the morning Androgen deprivation therapy (ADT) will be administered using analogues of luteinizing hormone-releasing hormone (aLHRH): * goserelin (at a dose of 3.6mg every 28 days or 10.8 mg every 84 days, subcutaneously, into the anterior abdominal wall), or * leuprorelin (7.5 mg every 28 days or 22.5 mg every 3 months, subcutaneously, into the anterior abdominal wall), or * triptorelin (3.75 mg every 28 days intramuscularly), or * buserelin (3.75 mg every 28 days, intramuscularly)
Drug: RS-113, 240 mg · Drug: Androgen deprivation therapy (ADT)
RS-113 is taken orally QD, 4 capsules at a time (320 mg), 1 hour after a meal in the morning Androgen deprivation therapy (ADT) will be administered using analogues of luteinizing hormone-releasing hormone (aLHRH): * goserelin (at a dose of 3.6mg every 28 days or 10.8 mg every 84 days, subcutaneously, into the anterior abdominal wall), or * leuprorelin (7.5 mg every 28 days or 22.5 mg every 3 months, subcutaneously, into the anterior abdominal wall), or * triptorelin (3.75 mg every 28 days intramuscularly), or * buserelin (3.75 mg every 28 days, intramuscularly)
Drug: RS-113, 320 mg · Drug: Androgen deprivation therapy (ADT)
Abiraterone is taken at a dose of 1000 mg (4 tablets of 250 mg) QD, 1 hour before a meal or 2 hours after a meal in combination with prednisolone at a dose of 10 mg (2 tablets of 5 mg) QD Androgen deprivation therapy (ADT) will be administered using analogues of luteinizing hormone-releasing hormone (aLHRH): * goserelin (at a dose of 3.6mg every 28 days or 10.8 mg every 84 days, subcutaneously, into the anterior abdominal wall), or * leuprorelin (7.5 mg every 28 days or 22.5 mg every 3 months, subcutaneously, into the anterior abdominal wall), or * triptorelin (3.75 mg every 28 days intramuscularly), or * buserelin (3.75 mg every 28 days, intramuscularly)
Drug: Abiraterone · Drug: Prednisolone · Drug: Androgen deprivation therapy (ADT)
Hard gelatin capsules, 80 mg
Also known as: L01069
Hard gelatin capsules, 80 mg
Also known as: L01069
Hard gelatin capsules, 80 mg
Also known as: L01069
Tablets, 250 mg
Tablets, 5 mg
* Goserelin: subcutaneous implant, 3.6 mg or 10.8 mg, or * Leuprorelin: lyophilisate for solution for subcutaneous injection, 7.5 mg or 22.5 mg, or * Triptorelin: lyophilisate for solution for intramuscular injection, 3.75 mg, or * Buserelin: lyophilisate for solution for intramuscular injection, 3.75 mg
Median Progression-free survival (PFS) at 1 year in RS-113 treatment arms
Progression-free survival (PFS) expressed as the median PFS for a period of up to 1 year of treatment inclusive in RS-113 treatment arms (per RECIST 1.1 and PCWG3 criteria) PFS is defined as the time from randomization to disease progression per RECIST 1.1 (an ≥ 20% increase in the sum of diameters of target lesions taking as reference the smallest sum recorded during the study (with an absolute increase of sum at least 5 mm), or the appearance of ≥ 1 new lesions), or death due to any cause According to PCWG3, progression is defined as: * two or more new lesions detected on the first post-baseline scan with at least 2 additional lesions on a subsequent scan * two or more new lesions detected on a subsequent scan (if one or no new lesions were seen at the first post-baseline scan) and confirmed by a follow-up scan
Time frame: Up to day 337 (visit 16)
Progression-free survival (PFS) rate (%) at 1 year in RS-113 treatment arms
Progression-free survival (PFS) expressed as the rate (%) at 1 year PFS in RS-113 treatment arms (per RECIST 1.1 and PCWG3 criteria) PFS is defined as the time from randomization to disease progression per RECIST 1.1 (an ≥ 20% increase in the sum of diameters of target lesions taking as reference the smallest sum recorded during the study (with an absolute increase of sum at least 5 mm), or the appearance of ≥ 1 new lesions), or death due to any cause According to PCWG3, progression is defined as: * two or more new lesions detected on the first post-baseline scan with at least 2 additional lesions on a subsequent scan * two or more new lesions detected on a subsequent scan (if one or no new lesions were seen at the first post-baseline scan) and confirmed by a follow-up scan
Time frame: Up to day 337 (visit 16)
Prostate-specific antigen (PSA) response rate (%) in RS-113 treatment arms
Prostate-specific antigen (PSA) response rate (%) in RS-113 treatment arms
Time frame: at Week 9, 21, 33, 45, 57, 69, 81, 93, 101 and FU visit
Number (%) of patients achieved ≥50% prostate-specific antigen (PSA) decline in RS-113 treatment arms
Number (%) of patients achieved ≥50% PSA decline at 6, 12, 18 and 24 months in RS-113 treatment arms Defined as a ≥50% reduction in PSA level from baseline at any time post-baseline. The response must be confirmed by the next PSA assessment performed at least 2 weeks later
Time frame: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit
Number (%) of patients achieved ≥90% prostate-specific antigen (PSA) decline in RS-113 treatment arm
Number (%) of patients achieved ≥90% PSA decline at 6, 12, 18 and 24 months in RS-113 treatment arm Defined as a ≥90% reduction in PSA level from baseline at any time post-baseline. The response must be confirmed by the next PSA assessment performed at least 2 weeks later
Time frame: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit
Objective response rate (ORR)(%) at 1 year in RS-113 treatment arms
The objective response rate (ORR)(%) is defined as the percentage of patients in RS-113 treatment arms who achieve a complete or partial response per RECIST 1.1: * Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \< 10 mm * Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks taking as reference the baseline sum at screening
Time frame: once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit
Disease control rate (DCR)(%) at 1 year in RS-113 treatment arms
The disease control rate is defined as the percentage of patients in RS-113 treatment arms who achieve a complete response, partial response, or stable disease during treatment per RECIST 1.1: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \<10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks taking as reference the baseline (screening) measurements * Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease taking as reference the smallest sum recorded during the study
Time frame: once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit
Time to Tumor Response (TTR) at 1 year in RS-113 treatment arms
Time to Tumor Response (TTR) at 1 year in RS-113 treatment arms
Time frame: once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit
Duration of Response (DOR) at 1 year in RS-113 treatment arms
Duration of Response (DOR) at 1 year in RS-113 treatment arms
Time frame: once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit
Time to prostate-specific antigen (PSA) progression in RS-113 treatment arms
Time to PSA progression is the time from randomization to the earliest date of confirmed PSA progression (per PCWG3 criteria). The date of PSA progression is defined as the date of a documented ≥25% increase in PSA and an absolute increase of ≥2 ng/mL above the nadir (or above baseline for patients with no PSA decline by Week 12), confirmed by two consecutive values obtained at least 3 weeks apart
Time frame: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit
Radiographic Progression-Free Survival (rPFS) at 1 year in RS-113 treatment arms
Radiographic Progression-Free Survival (rPFS) in RS-113 treatment arms, expressed as median rPFS for a period of up to 1 year of treatment inclusive (defined as the time from randomization to the first objective evidence of radiographic disease progression per RECIST 1.1 criteria or death due to any cause)
Time frame: Up to day 337 (visit 16)
Overall survival (OS) rate (%) at 1 year in RS-113 treatment arms
Overall survival (OS) expressed as the rate (%) at 1 year OS in RS-113 treatment arms
Time frame: Up to day 337 (visit 16)
Number of patients (%) with adverse drug reactions (ADRs) of any severity
Number of patients (%) with adverse drug reactions (ADRs) of any severity
Time frame: Up to day 701 (visit 29)
Number of patients (%) with adverse events (AEs) of any severity
Number of patients (%) with adverse events (AEs) of any severity
Time frame: Up to day 701 (visit 29)
Number of patients (%) with AEs grade ≥ 3 per CTCAE v. 5.0
Number of patients (%) with AEs grade ≥ 3 per CTCAE v. 5.0
Time frame: Up to day 701 (visit 29)
Number of patients (%) with ADRs grade ≥ 3 per CTCAE v. 5.0
Number of patients (%) with ADRs grade ≥ 3 per CTCAE v. 5.0
Time frame: Up to day 701 (visit 29)
Number of patients (%) with serious adverse events (SAEs)
Number of patients (%) with serious adverse events (SAEs) SAEs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0
Time frame: Up to day 701 (visit 29)
Number of patients (%) with serious adverse drug reactions (SADRs)
Number of patients (%) with serious adverse drug reactions (SADRs) SADRs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0
Time frame: Up to day 701 (visit 29)
Number of patients (%) who required discontinuation of treatment due to development of ADRs
Number of patients (%) who required discontinuation of treatment due to development of ADRs ADRs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0
Time frame: Up to day 701 (visit 29)
Number of patients (%) who required discontinuation of treatment due to development of SADRs
Number of patients (%) who required discontinuation of treatment due to development of SADRs SADRs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0
Time frame: Up to day 701 (visit 29)
Median progression-free survival (PFS) at 1 year (comparative assesment)
Progression-free survival (PFS) expressed as the median PFS for a period of up to 1 year of treatment inclusive (per RECIST 1.1 and PCWG3 criteria) (comparative assessment of median PFS at 1 year in each RS-113 treatment arm versus abiraterone plus prednisolone) PFS is defined as the time from randomization to disease progression per RECIST 1.1 (an ≥ 20% increase in the sum of diameters of target lesions taking as reference the smallest sum recorded during the study (with an absolute increase of sum at least 5 mm), or the appearance of ≥ 1 new lesions), or death due to any cause According to PCWG3, progression is defined as: * two or more new lesions detected on the first post-baseline scan with at least 2 additional lesions on a subsequent scan * two or more new lesions detected on a subsequent scan (if one or no new lesions were seen at the first post-baseline scan) and confirmed by a follow-up scan
Time frame: Up to day 337 (visit 16)
Progression-free survival (PFS) rate (%) at 1 year (comparative assessment)
Progression-free survival (PFS) expressed as the rate (%) at 1 year PFS (per RECIST 1.1 and PCWG3 criteria) (comparative assessment of PFS rate (%) at 1 year in each RS-113 treatment arm versus abiraterone plus prednisolone) PFS is defined as the time from randomization to disease progression per RECIST 1.1 (an ≥ 20% increase in the sum of diameters of target lesions taking as reference the smallest sum recorded during the study (with an absolute increase of sum at least 5 mm), or the appearance of ≥ 1 new lesions), or death due to any cause According to PCWG3, progression is defined as: * two or more new lesions detected on the first post-baseline scan with at least 2 additional lesions on a subsequent scan * two or more new lesions detected on a subsequent scan (if one or no new lesions were seen at the first post-baseline scan) and confirmed by a follow-up scan
Time frame: Up to day 337 (visit 16)
Median progression-free survival (PFS) at 2 years (comparative assesment)
Progression-free survival (PFS) expressed as the median PFS for a period of up to 2 years of treatment inclusive (per RECIST 1.1 and PCWG3 criteria) (comparative assessment of median PFS at 2 years in each RS-113 treatment arm versus abiraterone plus prednisolone) PFS is defined as the time from randomization to disease progression per RECIST 1.1 (an ≥ 20% increase in the sum of diameters of target lesions taking as reference the smallest sum recorded during the study (with an absolute increase of sum at least 5 mm), or the appearance of ≥ 1 new lesions), or death due to any cause According to PCWG3, progression is defined as: * two or more new lesions detected on the first post-baseline scan with at least 2 additional lesions on a subsequent scan * two or more new lesions detected on a subsequent scan (if one or no new lesions were seen at the first post-baseline scan) and confirmed by a follow-up scan
Time frame: Up to day 701 (visit 29)
Progression-free survival (PFS) rate (%) at 2 years (comparative assessment)
Progression-free survival (PFS) expressed as the rate (%) of 2-years PFS (per RECIST 1.1 and PCWG3 criteria) (comparative assessment of PFS rate (%) at 2 years in each RS-113 treatment arm versus abiraterone plus prednisolone) PFS is defined as the time from randomization to disease progression per RECIST 1.1 (an ≥ 20% increase in the sum of diameters of target lesions taking as reference the smallest sum recorded during the study (with an absolute increase of sum at least 5 mm), or the appearance of ≥ 1 new lesions), or death due to any cause According to PCWG3, progression is defined as: * two or more new lesions detected on the first post-baseline scan with at least 2 additional lesions on a subsequent scan * two or more new lesions detected on a subsequent scan (if one or no new lesions were seen at the first post-baseline scan) and confirmed by a follow-up scan
Time frame: Up to day 701 (visit 29)
Prostate-specific antigen (PSA) response rate (%) (comparative assessment)
Prostate-specific antigen (PSA) response rate (%) (comparative assessment of PSA response rate (%) in each RS-113 treatment arm versus abiraterone plus prednisolone)
Time frame: once at screening, on days 57 (week 9), 141 (week 21), 225 (week 33), 309 (week 45), 393 (week 57), 477 (week 69), 561 (week 81), 645 (week 93), 701 (week 101) and FU visit
Number (%) of patients achieved ≥50% prostate-specific antigen (PSA) decline (comparative assessment)
Number (%) of patients achieved ≥50% PSA decline at 6, 12, 18 and 24 months (comparative assessment of PSA response rate (%) in each RS-113 treatment arm versus abiraterone plus prednisolone) Defined as a ≥50% reduction in PSA level from baseline at any time post-baseline. The response must be confirmed by the next PSA assessment performed at least 2 weeks later
Time frame: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit
Number (%) of patients achieved ≥90% prostate-specific antigen (PSA) decline (comparative assessment)
Number (%) of patients achieved ≥90% PSA decline at 6, 12, 18 and 24 months (comparative assessment of PSA response rate (%) in each RS-113 treatment arm versus abiraterone plus prednisolone) Defined as a ≥90% reduction in PSA level from baseline at any time post-baseline. The response must be confirmed by the next PSA assessment performed at least 2 weeks later
Time frame: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit
Objective response rate (ORR)(%) at 1 year (comparative assessment)
Objective response rate (ORR)(%) at 1 year (comparative assessment of ORR in each RS-113 treatment arm versus abiraterone plus prednisolone) The ORR is defined as the percentage of patients in each RS-113 treatment arm versus abiraterone plus prednisolone who achieve a complete or partial response per RECIST 1.1: * Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \< 10 mm * Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks taking as reference the baseline sum at screening
Time frame: once at screening, on days 57 (visit 5), (visit 8), 113 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit
Objective response rate (ORR)(%) at 2 years (comparative assessment)
Objective response rate (ORR)(%) at 2 years (comparative assessment of ORR in each RS-113 treatment arm versus abiraterone plus prednisolone) The ORR is defined as the percentage of patients in each RS-113 treatment arm versus abiraterone plus prednisolone who achieve a complete or partial response per RECIST 1.1: * Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \< 10 mm * Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks taking as reference the baseline sum at screening
Time frame: once at screening, on days 57 (visit 5), (visit 8), 113 (visit 10), 253 (visit 13), 337 (visit 16), 421 (visit 19), 505 (visit 22), 589 (visit 25), 673 (visit 28) and FU visit
Disease control rate (DCR)(%) at 1 year (comparative assessment)
Disease control rate (DCR)(%) at 1 year (comparative assessment of DCR in each RS-113 treatment arm versus abiraterone plus prednisolone) The DCR is defined as the percentage of patients in each RS-113 treatment arm versus abiraterone plus prednisolone who achieve a complete response, partial response, or stable disease during treatment per RECIST 1.1: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \<10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks taking as reference baseline (screening) measurements * Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease taking as reference the smallest sum recorded during the study
Time frame: once at screening, on days 57 (visit 5), (visit 8), 113 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit
Disease control rate (DCR)(%) at 2 years (comparative assessment)
Disease control rate (DCR)(%) at 2 years (comparative assessment of DCR in each RS-113 treatment arm versus abiraterone plus prednisolone) The DCR is defined as the percentage of patients in each RS-113 treatment arm versus abiraterone plus prednisolone who achieve a complete response, partial response, or stable disease during treatment per RECIST 1.1: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \<10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks taking as reference baseline (screening) measurements * Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease taking as reference the smallest sum recorded during the study
Time frame: once at screening, on days 57 (visit 5), (visit 8), 113 (visit 10), 253 (visit 13), 337 (visit 16), 421 (visit 19), 505 (visit 22), 589 (visit 25), 673 (visit 28) and FU visit
Time to Tumor Response (TTR) at 1 year (comparative assessment)
Time to Tumor Response (TTR) at 1 year (comparative assessment of TTR in each RS-113 treatment arm versus abiraterone plus prednisolone)
Time frame: once at screening, on days 57 (visit 5), (visit 8), 113 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit
Time to Tumor Response (TTR) at 2 years (comparative assessment)
Time to Tumor Response (TTR) at 2 years (comparative assessment of TTR in each RS-113 treatment arm versus abiraterone plus prednisolone)
Time frame: once at screening, on days 57 (visit 5), (visit 8), 113 (visit 10), 253 (visit 13), 337 (visit 16), 421 (visit 19), 505 (visit 22), 589 (visit 25), 673 (visit 28) and FU visit
Duration of Response (DOR) at 1 year (comparative assessment)
Duration of Response (DOR) at 1 year (comparative assessment of DOR in each RS-113 treatment arm versus abiraterone plus prednisolone)
Time frame: once at screening, on days 57 (visit 5), (visit 8), 113 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit
Duration of Response (DOR) at 2 years (comparative assessment)
Duration of Response (DOR) at 2 years (comparative assessment of DOR in each RS-113 treatment arm versus abiraterone plus prednisolone)
Time frame: once at screening, on days 57 (visit 5), (visit 8), 113 (visit 10), 253 (visit 13), 337 (visit 16), 421 (visit 19), 505 (visit 22), 589 (visit 25), 673 (visit 28) and FU visit
Time to prostate-specific antigen (PSA) progression (comparative assessment)
Time to prostate-specific antigen (PSA) progression (comparative assessment of time to PSA progression in each RS-113 treatment arm versus abiraterone plus prednisolone) Time to PSA progression is the time from randomization to the earliest date of confirmed PSA progression (per PCWG3 criteria). The date of PSA progression is defined as the date of a documented ≥25% increase in PSA and an absolute increase of ≥2 ng/mL above the nadir (or above baseline for patients with no PSA decline by Week 12), confirmed by two consecutive values obtained at least 3 weeks apart
Time frame: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit
Radiographic Progression-Free Survival (rPFS) at 1 year in each RS-113 treatment arm versus abiraterone plus prednisolone (comparative assessment)
Radiographic Progression-Free Survival (rPFS) in each RS-113 treatment arm versus abiraterone plus prednisolone, expressed as median rPFS for a period of up to 1 year of treatment inclusive (defined as the time from randomization to the first objective evidence of radiographic disease progression per RECIST 1.1 criteria or death due to any cause)(comparative assessment of rPFS in each RS-113 treatment arm versus abiraterone plus prednisolone)
Time frame: Up to day 337 (visit 16)
Radiographic Progression-Free Survival (rPFS) at 2 years in each RS-113 treatment arm versus abiraterone plus prednisolone (comparative assessment)
Radiographic Progression-Free Survival (rPFS) in each RS-113 treatment arm versus abiraterone plus prednisolone, expressed as median rPFS for a period of up to 2 years of treatment inclusive (defined as the time from randomization to the first objective evidence of radiographic disease progression per RECIST 1.1 criteria or death due to any cause)(comparative assessment of rPFS in each RS-113 treatment arm versus abiraterone plus prednisolone)
Time frame: Up to day 701 (visit 29)
Change in pain intensity from baseline per the BPI-SF questionnaire (comparative assessment)
Change in pain intensity from baseline per the BPI-SF questionnaire at 6, 12, 18, and 24 months of treatment, and at the first follow-up visit (comparative assessment in each RS-113 treatment arm versus abiraterone plus prednisolone) When completing the BPI-SF (Brief Pain Inventory-Short Form), patients identify pain locations (graphically on a body diagram), rate pain intensity (from 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), and assess the degree of pain interference with quality of life (from 0 \[does not interfere\] to 10 \[completely interferes\])
Time frame: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit
Time to pain progression per the BPI-SF questionnaire (comparative assessment)
Time to pain progression per the BPI-SF questionnaire (comparative assessment in each RS-113 treatment arm versus abiraterone plus prednisolone) Time to pain progression is the interval from baseline to the date when the participant, according to Item 3 of the Brief Pain Inventory-Short Form (BPI-SF), demonstrates a ≥2-point increase in pain intensity from baseline, observed at two consecutive assessments ≥4 weeks apart, or the initiation of regular opioid use, whichever occurs first
Time frame: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit
Change in quality of life from baseline per the FACT-P (version 4) questionnaire (comparative assessment)
Change in quality of life from baseline per the FACT-P (version 4) questionnaire at 6, 12, 18, and 24 months of treatment, and at the first follow-up visit (comparative assessment in each RS-113 treatment arm versus abiraterone plus prednisolone)
Time frame: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit
Change in quality of life from baseline per the EQ-5D-5L questionnaire (comparative assessment)
Change in quality of life from baseline per the EQ-5D-5L) questionnaire at 6, 12, 18, and 24 months of treatment, and at the first follow-up visit (comparative assessment in each RS-113 treatment arm versus abiraterone plus prednisolone)
Time frame: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit
Overall survival (OS) rate (%) at 1 year (comparative assessment)
Overall survival (OS) expressed as the rate (%) at 1 year OS (comparative assessment in each RS-113 treatment arm versus abiraterone plus prednisolone)
Time frame: Up to day 337 (visit 16)
Overall survival (OS) rate (%) at 2 years (comparative assessment)
Overall survival (OS) expressed as the rate (%) of 2-years OS (comparative assessment in each RS-113 treatment arm versus abiraterone plus prednisolone)
Time frame: Up to day 701 (visit 29)
Area under the plasma drug concentration-time curve (AUC) of RS-113 from time 0 to 24 hours (AUC(0-24))
Area under the plasma drug concentration-time curve (AUC) of RS-113 from time 0 to 24 hours after the first (single dose) dose, truncated at the point before the second dose, i.e. up to 24 hours (AUC(0-24))
Time frame: Pre-dose on Day 1 (<30 min before the first dose) and 3 h ± 15 min, 6 h ± 30 min, 10 h ± 30 min, 14 h ± 30 min, 17 h ± 30 min, 22 h ± 30 min, 23 h 55 min ± 30 min post-dose
Maximum plasma concentration of RS-113 after the first dose (Cmax)
Maximum plasma concentration of RS-113 after the first dose (Cmax)
Time frame: Pre-dose on Day 1 (<30 min before the first dose) and 3 h ± 15 min, 6 h ± 30 min, 10 h ± 30 min, 14 h ± 30 min, 17 h ± 30 min, 22 h ± 30 min, 23 h 55 min ± 30 min post-dose
Time to reach maximum (peak) plasma concentration of RS-113 following the first dose (Tmax)
Time to reach maximum (peak) plasma concentration of RS-113 following the first dose (Tmax)
Time frame: Pre-dose on Day 1 (<30 min before the first dose) and 3 h ± 15 min, 6 h ± 30 min, 10 h ± 30 min, 14 h ± 30 min, 17 h ± 30 min, 22 h ± 30 min, 23 h 55 min ± 30 min post-dose
Volume of distribution of RS-113 after the first dose (Vd)
Volume of distribution of RS-113 after the first dose (Vd)
Time frame: Pre-dose on Day 1 (<30 min before the first dose) and 3 h ± 15 min, 6 h ± 30 min, 10 h ± 30 min, 14 h ± 30 min, 17 h ± 30 min, 22 h ± 30 min, 23 h 55 min ± 30 min post-dose
Maximum plasma concentration of RS-113 at steady state (Cmax ss)
Maximum plasma concentration of RS-113 at steady state (Cmax ss)
Time frame: Pre-dose on Day 15 (<30 min before the 15th administration) and 3 h ± 15 min, 6 h ± 30 min, 10 h ± 30 min, 14 h ± 30 min, 17 h ± 30 min, 22 h ± 30 min, 23 h 55 min ± 30 min post-dose
Minimum plasma concentration of RS-113 at steady state (Cmin ss)
Minimum plasma concentration of RS-113 at steady state (Cmin ss)
Time frame: Pre-dose on Day 15 (<30 min before the 15th dose) and 3 h ± 15 min, 6 h ± 30 min, 10 h ± 30 min, 14 h ± 30 min, 17 h ± 30 min, 22 h ± 30 min, 23 h 55 min ± 30 min post-dose
Area under the plasma drug concentration-time curve (AUC) of RS-113 at steady state (AUCtau ss)
Area under the plasma drug concentration-time curve (AUC) of RS-113 at steady state (AUCtau ss)
Time frame: Pre-dose on Day 15 (<30 min before the 15th dose) and 3 h ± 15 min, 6 h ± 30 min, 10 h ± 30 min, 14 h ± 30 min, 17 h ± 30 min, 22 h ± 30 min, 23 h 55 min ± 30 min post-dose
Time to reach maximum (peak) plasma concentration of RS-113 at steady state (Tmax ss)
Time to reach maximum (peak) plasma concentration of RS-113 at steady state (Tmax ss)
Time frame: Pre-dose on Day 15 (<30 min before the 15th dose) and 3 h ± 15 min, 6 h ± 30 min, 10 h ± 30 min, 14 h ± 30 min, 17 h ± 30 min, 22 h ± 30 min, 23 h 55 min ± 30 min post-dose
Volume of distribution of RS-113 at steady state (Vd ss)
Volume of distribution of RS-113 at steady state (Vd ss)
Time frame: Pre-dose on Day 15 (<30 min before the 15th dose) and 3 h ± 15 min, 6 h ± 30 min, 10 h ± 30 min, 14 h ± 30 min, 17 h ± 30 min, 22 h ± 30 min, 23 h 55 min ± 30 min post-dose
Residual concentration of RS-113 at steady state (Cthrough)
Residual concentration of RS-113 at steady state (Cthrough)
Time frame: Pre-dose on Day 15 (<30 min before the 15th dose) and 3 h ± 15 min, 6 h ± 30 min, 10 h ± 30 min, 14 h ± 30 min, 17 h ± 30 min, 22 h ± 30 min, 23 h 55 min ± 30 min post-dose
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