CompletedNCT02139826Updated Aug 20, 2020Results posted

Relative Bioavailability and Food Effect Study of IX-01 Capsules in Healthy Men

A Phase 1 interventional study of IX-01 in Healthy Participants, sponsored by Ixchelsis Limited. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by Ixchelsis Limited · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Male

Study summary

The purpose of this study is to compare the absorption and blood levels of IX-01 when given as a capsule compared to liquid form, and how food affects the absorption in healthy men.

Conditions studied

Healthy Participants

In context

Lead sponsor

Ixchelsis Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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.

Inclusion criteria

A (Quetelet index) in the range 18-30 kilograms/meters squared (kg/m2)
Body Mass Index = weight [kg] divided by (height [m])2
Total body weight greater than (>)50 kg at screening
Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial
Participants and their partners must be willing to use adequate forms of and to comply with the contraception requirements during the trial and for 4 months after the last dose of medication
Willingness to give written consent to have data entered into The Over Volunteering Prevention System

Exclusion criteria

Exclusion Criteria:

abnormal history, physical findings, , or laboratory values at the pre-trial screening assessment, including:
- Lipid and/or liver function test results >1.25 x (ULN) or other clinical laboratory blood biochemistry test results outside the normal reference range unless discussed and approved by sponsor
- (INR) of >1.2 or a count \< 150 x 109/Liter
- History of unexplained syncope
- Family history of unexplained sudden death, or sudden death due to long syndrome
- Fridericia Correction Formula (QTcF) interval >450 milliseconds (msec) at screening
- Bundle branch block and other conduction abnormalities, other than mild first degree atrio-ventricular block
- Irregular rhythms other than sinus arrhythmia or occasional supraventricular ectopic beats
- T-wave configuration of insufficient quality for determination of QT interval, as assessed by the investigator
Presence of acute or chronic illness or history of chronic illness sufficient to invalidate participation in the trial
Impaired gastrointestinal, endocrine, thyroid, hepatic, cardiovascular, respiratory, haematological, renal or neurological function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness
Surgery (for example (e.g.) stomach bypass) or medical condition that might affect absorption, metabolism or elimination of medicines
Any skin condition, abnormality of the lumbar spine, medical or surgical condition that would preclude lumbar puncture (e.g. coagulopathy, local or systemic infection, left ventricular outflow obstruction, aortic stenosis, previous back surgery)
Presence or history of severe adverse reaction to any drug
Use of any prescription or over-the-counter medicine during the 14 days before the first dose of trial medication, or intention to use any medicine during the trial, with the exception of short courses of medication considered by the investigator not to interfere with the safety of the participant or the integrity of the trial data (such as acetaminophen (paracetamol))
Current use of any herbal remedy or nutritional supplement, or intention to use any such product during the study
Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months.
Previous participation in this trial or any other clinical trial of an oxytocin receptor antagonist
Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly or more than 5 cigarettes daily
Blood pressure and heart rate in supine position at the screening examination outside the ranges 100-130 millimeters of mercury (mm Hg) systolic, 60-90 mm Hg diastolic; heart rate 50-100 beats/minute. Measurements must be made in duplicate, and all values must fall within the acceptable ranges
Possibility that the participant will not cooperate with the requirements of the protocol
Evidence of drug abuse on urine testing
Positive test for , , 1 (HIV1) or Human Immunodeficiency Virus 2 (HIV2)
Loss of more than 400 mL blood during the 3 months before the trial, e.g. as a blood donor
Objection by General Practitioner (GP), on medical grounds, to participant entering trial
Employee of the investigator site or any company involved in sponsoring, organizing or conducting the trial, or immediate family of the employee

Terms in these criteria, in plain language(11)

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.

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.

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.

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.

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.

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.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

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.

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.

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.

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.

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 12 participants (actual)

Study arms

Experimental
IX-01 Capsule while Fasting
Singe oral dose of 800 milligrams of IX-01 as a capsule, while fasting, in 1 of 3 treatment periods
Drug: IX-01
Experimental
IX-01 Aqueous Dispersion while Fasting
Single oral dose of 800 milligrams IX-01 as an aqueous dispersion, while fasting in 1 of 3 treatment periods
Drug: IX-01
Experimental
IX-01 Capsule after Food
Single oral dose of 800 milligrams IX-01 as a capsule, after food, in 1 of 3 treatment periods
Drug: IX-01

Interventions

DrugIX-01

What researchers measure

Primary outcomes

Relative Bioavailability (Frel) of a Capsule Compared to a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Time frame: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in the Fed State Compared to the Fasted State, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Time frame: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Compared With a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Peak Plasma Concentrations
Time frame: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in a Fed State Compared to a Fasted State, as Calculated by a Ratio of Peak Plasma Concentrations
Time frame: Pre-dose up to 96 hours post dose
Area Under the Plasma Concentration Time Curve From Time 0 to Infinity, Following a Single Dose of IX-01
Time frame: Pre-dose and up to 96 hours post dose
Peak Plasma Concentration (Cmax) of IX-01
Time frame: Pre-dose and up to 96 hours post dose
Time to Peak Plasma Concentration (Tmax) of IX-01
Time frame: Pre-dose up to 96 hours post dose
Elimination Half Life (t1/2) of IX-01
Time frame: Pre-dose up to 96 hours post dose
Elimination Rate Constant (Kel) of IX-01
Time frame: Pre-dose up to 96 hours post last dose
Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Measurable Sample of IX-01
Time frame: Pre-dose to the time of the last measurable sample
Concentration of IX-01 in Cerebrospinal Fluid (CSF) After a Single Dose of the Liquid Formulation of IX-01
Listed by time point of 1, 2, 4, 6 hours post dose
Time frame: 1, 2, 4 and 6 hours after dosing

Secondary outcomes

Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs
Time frame: Baseline to study completion (approximately 6 weeks)

Results

Posted Aug 20, 2020

Participant flow

Participant flow — Overall Study
Milestone	Overall Study
Started	12
Completed	11
Not completed	1
Withdrew: Adverse event	1

Outcome measures

PrimaryRelative Bioavailability (Frel) of a Capsule Compared to a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity

Time frame:: Pre-dose up to 96 hours post dose
Reported as:: Geometric mean · Ratio: capsule fasted/acqueous fasted

Relative Bioavailability (Frel) of a Capsule Compared to a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Ratio: capsule fasted/acqueous fasted	IX-01 Capsule While Fasting
Relative Bioavailability (Frel) of a Capsule Compared to a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity	99.93 (90.8 to 109.98)

PrimaryRelative Bioavailability (Frel) of a Capsule Formulation of IX-01 in the Fed State Compared to the Fasted State, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity

Time frame:: Pre-dose up to 96 hours post dose
Reported as:: Geometric mean · Ratio: capsule fed/fasted

Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in the Fed State Compared to the Fasted State, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Ratio: capsule fed/fasted	IX-01 Capsule After Food
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in the Fed State Compared to the Fasted State, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity	148.85 (135.25 to 163.82)

PrimaryRelative Bioavailability (Frel) of a Capsule Compared With a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Peak Plasma Concentrations

Time frame:: Pre-dose up to 96 hours post dose
Reported as:: Geometric mean · Ratio: capsule/aqueous

Relative Bioavailability (Frel) of a Capsule Compared With a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Peak Plasma Concentrations
Ratio: capsule/aqueous	IX-01 Capsule While Fasting
Relative Bioavailability (Frel) of a Capsule Compared With a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Peak Plasma Concentrations	123.78 (96.76 to 158.36)

PrimaryRelative Bioavailability (Frel) of a Capsule Formulation of IX-01 in a Fed State Compared to a Fasted State, as Calculated by a Ratio of Peak Plasma Concentrations

Time frame:: Pre-dose up to 96 hours post dose
Reported as:: Geometric mean · Ratio: capsule fed/fasting

Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in a Fed State Compared to a Fasted State, as Calculated by a Ratio of Peak Plasma Concentrations
Ratio: capsule fed/fasting	IX-01 Capsule After Food
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in a Fed State Compared to a Fasted State, as Calculated by a Ratio of Peak Plasma Concentrations	175.46 (137.15 to 224.47)

PrimaryArea Under the Plasma Concentration Time Curve From Time 0 to Infinity, Following a Single Dose of IX-01

Time frame:: Pre-dose and up to 96 hours post dose
Reported as:: Geometric mean · h*ng/mL

Area Under the Plasma Concentration Time Curve From Time 0 to Infinity, Following a Single Dose of IX-01
h*ng/mL	IX-01 Aqueous Dispersion While Fasting	IX-01 Capsule While Fasting	IX-01 Capsule After Food
Area Under the Plasma Concentration Time Curve From Time 0 to Infinity, Following a Single Dose of IX-01	20465 ± 38.9	20522 ± 31.7	31613 ± 27.3

PrimaryPeak Plasma Concentration (Cmax) of IX-01

Time frame:: Pre-dose and up to 96 hours post dose
Reported as:: Geometric mean · ng/mL

Peak Plasma Concentration (Cmax) of IX-01
ng/mL	IX-01 Aqueous Dispersion While Fasting	IX-01 Capsule While Fasting	IX-01 Capsule After Food
Peak Plasma Concentration (Cmax) of IX-01	1147 ± 39.9	1428 ± 47.9	2518.5 ± 22.7

PrimaryTime to Peak Plasma Concentration (Tmax) of IX-01

Time frame:: Pre-dose up to 96 hours post dose
Reported as:: Median · hours

Time to Peak Plasma Concentration (Tmax) of IX-01
hours	IX-01 Aqueous Dispersion While Fasting	IX-01 Capsule While Fasting	IX-01 Capsule After Food
Time to Peak Plasma Concentration (Tmax) of IX-01	1 (0.5 to 8)	1.5 (0.75 to 4)	4 (2 to 8)

PrimaryElimination Half Life (t1/2) of IX-01

Time frame:: Pre-dose up to 96 hours post dose
Reported as:: Geometric mean · hours

Elimination Half Life (t1/2) of IX-01
hours	IX-01 Aqueous Dispersion While Fasting	IX-01 Capsule While Fasting	IX-01 Capsule After Food
Elimination Half Life (t1/2) of IX-01	15 ± 60.7	12.6 ± 32	12.2 ± 40.2

PrimaryElimination Rate Constant (Kel) of IX-01

Time frame:: Pre-dose up to 96 hours post last dose
Reported as:: Geometric mean · 1/h

Elimination Rate Constant (Kel) of IX-01
1/h	IX-01 Aqueous Dispersion While Fasting	IX-01 Capsule While Fasting	IX-01 Capsule After Food
Elimination Rate Constant (Kel) of IX-01	0.046 ± 60.7	0.055 ± 32	0.057 ± 40.2

PrimaryArea Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Measurable Sample of IX-01

Time frame:: Pre-dose to the time of the last measurable sample
Reported as:: Geometric mean · h*ng/mL

Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Measurable Sample of IX-01
h*ng/mL	IX-01 Aqueous Dispersion While Fasting	IX-01 Capsule While Fasting	IX-01 Capsule After Food
Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Measurable Sample of IX-01	19529 ± 34.5	20218 ± 31.1	31270 ± 26.7

PrimaryConcentration of IX-01 in Cerebrospinal Fluid (CSF) After a Single Dose of the Liquid Formulation of IX-01

Listed by time point of 1, 2, 4, 6 hours post dose

Time frame:: 1, 2, 4 and 6 hours after dosing
Reported as:: Mean · ng/mL

Concentration of IX-01 in Cerebrospinal Fluid (CSF) After a Single Dose of the Liquid Formulation of IX-01
ng/mL	IX-01 Aqueous Dispersion While Fasting
At 1 hour, 1 participant analyzed	27.8 ± 0
At 2 hours, 2 participants analyzed	24.4 ± 2.97
At 4 hours, 3 participants analyzed	54 ± 17.67
At 6 hours, 4 participants analyzed	40 ± 21.04

SecondaryNumber of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs

Time frame:: Baseline to study completion (approximately 6 weeks)
Reported as:: Number · participants

Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs
participants	IX-01 Aqueous Dispersion While Fasting	IX-01 Capsule While Fasting	IX-01 Capsule After Food
Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs	1	1	2

Adverse events

Collected over Up to 6 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
IX-01 Aqueous Dispersion While Fasting	—	0/11 (0%)	8/11 (72.7%)
IX-01 Capsule While Fasting	—	0/11 (0%)	3/11 (27.3%)
IX-01 Capsule After Food	—	0/12 (0%)	4/12 (33.3%)

Most frequent other events

Showing 10 of 14

Most frequent other events
Event	IX-01 Aqueous Dispersion While Fasting	IX-01 Capsule While Fasting	IX-01 Capsule After Food
Back painMusculoskeletal and connective tissue disorders	4/11	0/11	1/12
HeadacheNervous system disorders	2/11	2/11	1/12
PresyncopeNervous system disorders	2/11	0/11	0/12
Procedural HeadacheInjury, poisoning and procedural complications	1/11	0/11	0/12
DizzinessNervous system disorders	1/11	0/11	0/12
SomnolenceNervous system disorders	1/11	0/11	0/12
NauseaGastrointestinal disorders	1/11	0/11	0/12
ToothacheGastrointestinal disorders	0/11	1/11	0/12
NasopharyngitisInfections and infestations	1/11	0/11	1/12
RhinitisInfections and infestations	0/11	1/11	0/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Overall Study
Mean	32.5 ± 9.22

Sex: Female, Male
Sex: Female, Male(Participants)	Overall Study
Female	0
Male	12

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Overall Study
Hispanic or Latino	0
Not Hispanic or Latino	12
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Overall Study
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	10
More than one race	1
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Overall Study
United Kingdom	12

Study locations

1 site

Hammersmith Medicines Research
London, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02139826
Lead sponsor: Ixchelsis Limited
Responsible party: Sponsor
First posted: May 15, 2014
Start date: May 2014
Primary completion: Jun 2014
Completion: Jun 2014
Results posted: Aug 20, 2020
Last update: Aug 20, 2020

Study contacts

Email: Ixchelsis@Choruspharma.com

study director · Ixchelsis Limited

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: IX-01

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