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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139826
• Other study ID #: IX-0102
• Status: Completed
• Phase: Phase 1
• Start date: May 2014
• Est. completion date: June 2014

Study information

• Verified date: August 2020
• Source: Ixchelsis Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• IX-01

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Ixchelsis Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Pre-dose up to 96 hours post dose
Primary	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		Pre-dose up to 96 hours post dose
Primary	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		Pre-dose up to 96 hours post dose
Primary	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		Pre-dose up to 96 hours post dose
Primary	Area Under the Plasma Concentration Time Curve From Time 0 to Infinity, Following a Single Dose of IX-01		Pre-dose and up to 96 hours post dose
Primary	Peak Plasma Concentration (Cmax) of IX-01		Pre-dose and up to 96 hours post dose
Primary	Time to Peak Plasma Concentration (Tmax) of IX-01		Pre-dose up to 96 hours post dose
Primary	Elimination Half Life (t1/2) of IX-01		Pre-dose up to 96 hours post dose
Primary	Elimination Rate Constant (Kel) of IX-01		Pre-dose up to 96 hours post last dose
Primary	Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Measurable Sample of IX-01		Pre-dose to the time of the last measurable sample
Primary	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	1, 2, 4 and 6 hours after dosing
Secondary	Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs		Baseline to study completion (approximately 6 weeks)