- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02139826
Relative Bioavailability and Food Effect Study of IX-01 Capsules in Healthy Men
August 5, 2020 updated by: Ixchelsis Limited
A Randomised, Single-dose, 3-way Crossover Study to Evaluate the Relative Bioavailability of the IX-01 Capsule Formulation Compared With the IX-01 Aqueous Dispersion Formulation, and the Effect of Food on the IX-01 Capsule Formulation, in Healthy Male Subjects
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- Hammersmith Medicines Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- A body mass index (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 contraception 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:
Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment, including:
- Lipid and/or liver function test results >1.25 x Upper Limit of Normal (ULN) or other clinical laboratory blood biochemistry test results outside the normal reference range unless discussed and approved by sponsor
- International normalised ratio (INR) of >1.2 or a platelet count < 150 x 109/Liter
- History of unexplained syncope
- Family history of unexplained sudden death, or sudden death due to long QT 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 hepatitis B, hepatitis C, Human Immunodeficiency Virus 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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
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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
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Pre-dose up to 96 hours post dose
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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
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Pre-dose up to 96 hours post dose
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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
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Pre-dose up to 96 hours post dose
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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
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Pre-dose up to 96 hours post dose
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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
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Pre-dose and up to 96 hours post dose
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Peak Plasma Concentration (Cmax) of IX-01
Time Frame: Pre-dose and up to 96 hours post dose
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Pre-dose and up to 96 hours post dose
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Time to Peak Plasma Concentration (Tmax) of IX-01
Time Frame: Pre-dose up to 96 hours post dose
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Pre-dose up to 96 hours post dose
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Elimination Half Life (t1/2) of IX-01
Time Frame: Pre-dose up to 96 hours post dose
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Pre-dose up to 96 hours post dose
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Elimination Rate Constant (Kel) of IX-01
Time Frame: Pre-dose up to 96 hours post last dose
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Pre-dose up to 96 hours post last dose
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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
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Pre-dose to the time of the last measurable sample
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Concentration of IX-01 in Cerebrospinal Fluid (CSF) After a Single Dose of the Liquid Formulation of IX-01
Time Frame: 1, 2, 4 and 6 hours after dosing
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Listed by time point of 1, 2, 4, 6 hours post dose
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1, 2, 4 and 6 hours after dosing
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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Baseline to study completion (approximately 6 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Email: Ixchelsis@Choruspharma.com, Ixchelsis Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
May 12, 2014
First Submitted That Met QC Criteria
May 13, 2014
First Posted (Estimate)
May 15, 2014
Study Record Updates
Last Update Posted (Actual)
August 20, 2020
Last Update Submitted That Met QC Criteria
August 5, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- IX-0102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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