A Phase 1 interventional study of AZD6094 200 mg and Placebo in Solid Tumors, sponsored by AstraZeneca. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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Among 44 studies in Long QT Syndrome with a site in United States — 7 open to participants now, 7 under way, 1 of them phase 3. Long QT Syndrome · United States.
Among the 44 studies in Long QT Syndrome with a site in United States, this one is the 14th largest by enrollment of the 28 interventional ones that give a count, is the only one that started in 2017, is one of 10 in phase 1, and was the 29th registered.
101 studies on the registry are indexed under Long QT Syndrome; 20 are open to participants now.
Browse Long QT Syndrome studies →7 of the 44 studies in Long QT Syndrome with a site in United States are open now. Recruiting first, the newest first:
Thryv Therapeutics, Inc. · Sites in United States
Ages 15+
Washington University School of Medicine · Sites in United States
Ages 18+
University of Maryland, Baltimore · Sites in United States
Ages 18+
Medical College of Wisconsin · Sites in United States
Ages 18+ · Women only
Mayo Clinic · Sites in United States
Ages 18–50
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 14 Long QT Syndrome studies recruiting now, 10 (71%) set no upper age limit and 3 (21%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 55 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 4 · Phase 3 2 · Phase 4 5
First in 1985; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 45 is close to the median of 45 across 46 interventional studies indexed under Long QT Syndrome.
Median enrollment 44 across the 28 interventional studies, 96 across the 16 observational. Of the 33 that completed or were terminated, 14 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 44 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
AstraZeneca has 1 study filed under Long QT Syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in Long QT Syndrome with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07277582Phase 3Thryv Therapeutics, Inc.Evaluation of the Efficacy and Safety of THRV-1268 in Participants With Long QT Syndrome Type 2 (LQTS2) and Type 3 (LQTS3) | 2027-06-30 |
| NCT04336644Washington University School of MedicineContinuous Versus Intermittent cARdiac Electrical moNitorinG | 2026-12-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 44 studies in Long QT Syndrome with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a randomized, placebo-controlled, double-blind, 3-way crossover phase I study being conducted on healthy volunteers to investigate the effect of single dose of AZD6094 (600 mg) on cardiac repolarization under well-controlled conditions in accordance with the International Council for Harmonization (ICH) E14 guidelines. An open-label Moxifloxacin (400 mg), a fluoroquinolone broad spectrum antibiotic will be used as a appositive control for the time between the start of the Q wave and the end of the T wave (QT) prolongation in accordance with ICH E14 guidelines, to establish assay sensitivity. The core study consists of screening period, 3 treatment period (AZD6094, placebo and moxifloxacin; with a minimum washout period of 14 days between each treatment period) and follow-up. The study drugs will be administered orally. The study is planned to determine effect of AZD6094 at therapeutic dose, safety and tolerability. This study provides adequate and well-controlled mechanisms to deal with potential bias, facilitate identification of effects related to investigational product (IMP) administration and tolerability issues.
The study is planned to include approximately 45 healthy non-Japanese vasectomized male participants aged 18 to 55 years (inclusive) or male participants over 40 (and up to 55) years old not intending to father children will be enrolled. The study consists of 5 visits comprised of 3 treatment periods with 6 treatment sequences and will have a minimum washout period of 14 days between each treatment period.
Visit 1: Screening period (28 days) - Assessments done on Day -1 of treatment period 1.
Visits 2 to 4: 3 Treatment periods - Participants will be resident form day before IMP (single oral dose of AZD6094 (600 mg) tablet/AZD6094 matching placebo/moxifloxacin (400 mg) capsule) dosing (Day -1) until at least 48 hours post-dose and will be discharged on Day 3.
Visit 5: Follow-up - Participants will have clinical visit 14 days after discharge from the treatment period 3.
Participants will be randomized to 6 treatment sequences (ABC, ACB, BAC, BCA, CAB and CBA). In each sequence, participants will receive single oral dose of all 3 treatments (A - AZD6094 600 mg (3X 200 mg tablet), B - Placebo tablet, C - Moxifloxacin 400 mg capsule) with a washout period (14 days) between each treatment period.
The study duration will be approximately 84 days.
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.
Participants must fulfill the following criteria:
Exclusion Criteria:
Participants must not be randomized if any of the following exclusion criteria are fulfilled:
Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
Any clinically important abnormalities in rhythm, conduction or morphology of the 12-lead resting that may interfere with the interpretation of changes. These include healthy participants with any of the following:
Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
In addition, any of the following is regarded as a criterion for exclusion from the genetic research:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
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.
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.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
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.
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.
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.
Participants will receive orally single dose of study drugs in the sequence of ABC. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg
Drug: AZD6094 200 mg · Other: Placebo · Drug: Moxifloxacin
Participants will receive orally single dose of study drugs in the sequence of ACB. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg
Drug: AZD6094 200 mg · Other: Placebo · Drug: Moxifloxacin
Participants will receive orally single dose of study drugs in the sequence of BAC. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg
Drug: AZD6094 200 mg · Other: Placebo · Drug: Moxifloxacin
Participants will receive orally single dose of study drugs in the sequence of BCA. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg
Drug: AZD6094 200 mg · Other: Placebo · Drug: Moxifloxacin
Participants will receive orally single dose of study drugs in the sequence of CAB. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg
Drug: AZD6094 200 mg · Other: Placebo · Drug: Moxifloxacin
Participants will receive orally single dose of study drugs in the sequence of CBA. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg
Drug: AZD6094 200 mg · Other: Placebo · Drug: Moxifloxacin
A potent and selective small molecule mesenchymal epithelial transition (MET) kinase inhibitor with significant antitumor activity.
AZD6094 matching placebo without any pharmacological activity.
A fluoroquinolone broad-spectrum antibiotic, produces a mild, but reproducible increase in QT interval corrected (QTc) in healthy normal participants at time to reach maximum concentration (tmax - approximately 2 hours (0.5 to 4 hours)). This effect is close to the ECG interval measured from the onset of the QRS complex (onset of the QRS complex to the J point) to the offset of the T wave (QT)/QTc effect that represents the threshold of regulatory concern, around 5 ms mean QTc interval prolongation.
Also known as: Avelox
Effect of AZD6094 at single therapeutic dose (600 mg) on ventricular repolarization by analysis of change from baseline-corrected QT
To assess the effect of AZD6094 at single therapeutic dose (600mg) on ventricular repolarization by assessing the time matched baseline-adjusted, placebo subtracted QTc interval corrected for RR (R waves on electrocardiogram \[ECG\]) by the Fridericia formula (QTcF). The ECGs -digital (dECG) and page (pECG) would be recorded during the study for the assessment of safety. Paper ECG for safety review will be performed following the dECG recordings and at additional intervals if required.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment period (At pre-dose on Day -1 to Day 3, 48 hours post-dose) and follow-up (14 days after discharge from the treatment period 3)
Effect of AZD6094 at therapeutic dose (600 mg) on additional time-matched ECG variables
To assess the effect of AZD6094 at therapeutic dose (600 mg) on additional time matched ECG variables using the dECG and pECG records. The ECG variables includes Bazett corrected QT interval \[QTcB\], onset of the P wave to the onset of the QRS complex (PR), onset of the QRS complex to the J point (QRS), QT and time interval between corresponding points on 2 consecutive R waves on ECG (RR). Paper ECG for safety review will be performed following the dECG recordings and at additional intervals if required.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment period (At pre-dose on Day -1 to Day 3, 48 hours post-dose) and follow-up (14 days after discharge from the treatment period 3)
Effect of moxifloxacin 400 mg on Fridericia-corrected QT interval (QTcF) compared to placebo.
To assess the effect of moxifloxacin 400 mg on the QTcF interval compared to placebo. Paper ECG for safety review will be performed following the dECG recordings and at additional intervals if required.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment period (At pre-dose on Day -1 to Day 3, 48 hours post-dose) and follow-up (14 days after discharge from the treatment period 3)
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC(0-∞)) assessment for AZD6094, its metabolites (M2 and M3) and moxifloxacin
To assess AUC(0-∞) after administration of single oral dose of AZD6094, placebo and moxifloxacin. The pharmacokinetic (PK) sampling done post dose must precede with 10 minutes of rest followed by 5 minutes dECG.
Time frame: Treatment periods (At pre-dose (Day -1) and post-dose (30 min, 60 min, 90 min, 2 hours to 6 hours, 8 hours, 12 hours, 24 hours, 36 hours and 48 hours)
Area under the plasma concentration-time curve from time zero to t hours after dosing (AUC(0-t)) assessment for AZD6094, its metabolites (M2 and M3) and moxifloxacin
To assess AUC(0-t) after administration of single oral dose of AZD6094, placebo and moxifloxacin. The PK sampling done post dose must precede with 10 minutes of rest followed by 5 minutes dECG.
Time frame: Treatment periods (At pre-dose (Day -1) and post-dose (30 min, 60 min, 90 min, 2 hours to 6 hours, 8 hours, 12 hours, 24 hours, 36 hours and 48 hours)
Observed maximum concentration (Cmax) assessment for AZD6094, its metabolites (M2 and M3) and moxifloxacin
To assess Cmax after administration of single oral dose of AZD6094, placebo and moxifloxacin; Cmax will be taken directly from the individual concentration-time curve. The PK sampling done post-dose must precede with 10 minutes of rest followed by 5 minutes dECG.
Time frame: Treatment periods (At pre-dose (Day -1) and post-dose (30 min, 60 min, 90 min, 2 hours to 6 hours, 8 hours, 12 hours, 24 hours, 36 hours and 48 hours)
Time to reach maximum concentration (tmax) assessment for AZD6094, its metabolites (M2 and M3) and moxifloxacin
To assess tmax after administration of single oral dose of AZD6094, placebo and moxifloxacin; tmax will be taken directly from the individual concentration-time curve. The PK sampling done post-dose must precede with 10 minutes of rest followed by 5 minutes dECG.
Time frame: Treatment periods (At pre-dose (Day -1) and post-dose (30 min, 60 min, 90 min, 2 hours to 6 hours, 8 hours, 12 hours, 24 hours, 36 hours and 48 hours)
Lag-time (tlag - from the individual concentration-time curve) assessment for AZD6094, its metabolites (M2 and M3) and moxifloxacin
To assess lag-time (tlag) after administration of single oral dose of AZD6094, placebo and moxifloxacin; tlag will be taken directly from the individual concentration-time curve. The PK sampling done post-dose must precede with 10 minutes of rest followed by 5 minutes dECG.
Time frame: Treatment periods (At pre-dose (Day -1) and post-dose (30 min, 60 min, 90 min, 2 hours to 6 hours, 8 hours, 12 hours, 24 hours, 36 hours and 48 hours)
Terminal rate constant (λz) assessment for AZD6094, its metabolites (M2 and M3) and moxifloxacin
To assess λz after administration of single oral dose of AZD6094, placebo and moxifloxacin; λz will be estimated by log-linear least squares regression of the terminal part of the concentration-time curve. The PK sampling done post-dose must precede with 10 minutes of rest followed by 5 minutes dECG.
Time frame: Treatment periods (At pre-dose (Day -1) and post-dose (30 min, 60 min, 90 min, 2 hours to 6 hours, 8 hours, 12 hours, 24 hours, 36 hours and 48 hours)
Terminal half-life (t½) assessment for AZD6094, its metabolites (M2 and M3) and moxifloxacin
To assess t½ after administration of single oral dose of AZD6094, placebo and moxifloxacin. The PK sampling done post-dose must precede with 10 minutes of rest followed by 5 minutes dECG.
Time frame: Treatment periods (At pre-dose (Day -1) and post-dose (30 min, 60 min, 90 min, 2 hours to 6 hours, 8 hours, 12 hours, 24 hours, 36 hours and 48 hours)
Apparent clearance for parent drug estimated as dose divided by AUC (CL/F) assessment for AZD6094, its metabolites (M2 and M3) and moxifloxacin
To assess CL/F after administration of single oral dose of AZD6094, placebo and moxifloxacin. The PK sampling done post-dose must precede with 10 minutes of rest followed by 5 minutes dECG.
Time frame: Treatment periods (At pre-dose (Day -1) and post-dose (30 min, 60 min, 90 min, 2 hours to 6 hours, 8 hours, 12 hours, 24 hours, 36 hours and 48 hours)
Apparent volume of distribution for parent drug at terminal phase (Vz/F, extravascular administration) assessment for AZD6094, its metabolites (M2 and M3) and moxifloxacin
To assess apparent volume of distribution for parent drug at terminal phase (Vz/F, extravascular administration) after administration of single oral dose of AZD6094, placebo and moxifloxacin; Vz/F will be estimated by dividing the apparent clearance (CL/F) by λz. 10 min rest + 5 min dECG will always precede the PK sampling when coinciding post-dose.
Time frame: Treatment periods (At pre-dose (Day -1) and post-dose (30 min, 60 min, 90 min, 2 hours to 6 hours, 8 hours, 12 hours, 24 hours, 36 hours and 48 hours)
Assessment of relationship between the plasma concentration of AZD6094 and moxifloxacin and ECG variables, including baseline-adjusted and placebo-subtracted QTc interval.
To assess the effect of AZD6094 and moxifloxacin on ventricular repolarization by assessing the plasma concentration and ECG variables including baseline-adjusted and placebo subtracted QTc interval
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment period (At pre-dose on Day -1 to Day 3, 48 hours post-dose) and follow-up (14 days after discharge from the treatment period 3)
Number of participants with adverse events (AEs) of AZD6094
To assess AEs as a criteria of safety and tolerability. AEs will be collected from the start of Screening throughout the treatment period up to and including the Follow-up Visit (Visit 5). Serious AEs will be recorded from the time of informed consent.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment period (At pre-dose (Day -1) and post-dose (24 hours and 48 hours) and follow-up (14 days after discharge from the treatment period 3)
Systolic blood pressure [SBP]
To assess SBP as criteria of safety and tolerability variables. Blood pressure will be taken after the ECG.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment periods (At pre-dose on Day -1 to Day 3 (48 hours post-dose) and follow-up (14 days after discharge from the treatment Period 3)
Diastolic blood pressure [DBP]
To assess DBP as criteria of safety and tolerability variables. Blood pressure will be taken after the ECG.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment periods (At pre-dose on Day -1 to Day 3 (48 hours post-dose) and follow-up (14 days after discharge from the treatment Period 3)
Pulse rate
To assess pulse rate as criteria of safety and tolerability variables.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment periods (At pre-dose on Day -1 to Day 3 (48 hours post-dose) and follow-up (14 days after discharge from the treatment Period 3)
Twelve-lead (12-Lead) electrocardiograms (ECGs)
To assess the cardiovascular system functioning using 12-Lead dECG and pECG as a criteria of safety and tolerability variables.
Time frame: At screening, treatment periods (pre-dose and post-dose - 30 min, 60 min, 90 min, 2 hours to 6 hours, 8 hours, 12 hours and 24 hours) and follow-up visits
Physical examination
To assess the physical examination as a criteria of safety and tolerability variables. Brief physical examination will be performed at pre-dose on Day -1 at each treatment period; includes assessment of general appearance, skin, cardiovascular system, respiratory and abdomen. Full physical examination includes assessment of the general appearance, skin, cardiovascular, respiratory, abdomen, head, and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment periods (At pre-dose on Day -1 to Day 3 (48 hours post-dose) and follow-up (14 days after discharge from the treatment Period 3)
Laboratory assessments of Hematology
To assess the hematology (blood cells count, differential count and hemoglobin count) as a criteria of safety and tolerability variables. A reduced safety laboratory screen will be done at Day -1 or pre-dose at Day 1 and at 48 hours post-dose for all treatment periods.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment periods (At pre-dose on Day -1 to Day 3 (48 hours post-dose) and follow-up (14 days after discharge from the treatment Period 3)
Laboratory assessments of Clinical chemistry
To assess the clinical chemistry (electrolytes, glucose (fasting), C-reactive protein (CRP), liver enzymes, total and unconjugated bilirubin; at screening alone - free thyroxine and thyroid-stimulating hormone) as a criteria of safety and tolerability variables. A reduced safety laboratory screen will be done at Day -1 or pre-dose at Day 1 and at 48 hours post-dose for all treatment periods.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment periods (At pre-dose on Day -1 to Day 3 (48 hours post-dose) and follow-up (14 days after discharge from the treatment Period 3)
Laboratory assessments of urinalysis
To assess the urinalysis (glucose, protein and blood) as a criteria of safety and tolerability variables. If urinalysis is positive for protein or blood, a microscopy test will be performed to assess red blood cells (RBC), white blood cells (WBC), casts (cellular, granular, hyaline)). A reduced safety laboratory screen will be done at Day -1 or pre-dose at Day 1 and at 48 hours post-dose for all treatment periods.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment periods (At pre-dose on Day -1 to Day 3 (48 hours post-dose) and follow-up (14 days after discharge from the treatment Period 3)
Effect of AZD6094 at therapeutic dose (600 mg) on time-matched ECG variable - heart rate (HR)
To assess the effect of AZD6094 at therapeutic dose (600 mg) on additional time matched ECG variable - HR using the dECG and pECG records. Paper ECG for safety review will be performed following the dECG recordings and at additional intervals if required.
Time frame: At screening (28 days prior to Day 1 of treatment period 1), treatment period (At pre-dose on Day -1 to Day 3, 48 hours post-dose) and follow-up (14 days after discharge from the treatment period 3)
Ran from Sep 2017 to primary completion in Mar 2018, 6 months.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Savolitinib · Moxifloxacin