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

NCT02139826 | Completed Phase 1 Results

• 1 other identifier: IX-0102
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Healthy Participants

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• Peak Plasma Concentration (Cmax) of IX-01

  Pre-dose and up to 96 hours post dose

• Time to Peak Plasma Concentration (Tmax) of IX-01

  Pre-dose up to 96 hours post dose

• Elimination Half Life (t1/2) of IX-01

  Pre-dose up to 96 hours post dose

• Elimination Rate Constant (Kel) of IX-01

  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

  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

  1, 2, 4 and 6 hours after dosing

Secondary Outcomes (1)

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

  Baseline to study completion (approximately 6 weeks)

Study Arms (3)

IX-01 Capsule while Fasting

EXPERIMENTAL

Singe oral dose of 800 milligrams of IX-01 as a capsule, while fasting, in 1 of 3 treatment periods

Drug: IX-01

IX-01 Aqueous Dispersion while Fasting

EXPERIMENTAL

Single oral dose of 800 milligrams IX-01 as an aqueous dispersion, while fasting in 1 of 3 treatment periods

Drug: IX-01

IX-01 Capsule after Food

EXPERIMENTAL

Single oral dose of 800 milligrams IX-01 as a capsule, after food, in 1 of 3 treatment periods

Drug: IX-01

Interventions

IX-01 DRUG

IX-01 Aqueous Dispersion while Fasting; IX-01 Capsule after Food; IX-01 Capsule while Fasting

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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))

Sponsors & Collaborators

• Ixchelsis Limited: lead

Study Sites (1)

Hammersmith Medicines Research

London, United Kingdom

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Ixchelsis Limited

ian.osterloh@ixchelsis.com

44(0)1227-832760

Study Officials

• Email: Ixchelsis@Choruspharma.com

  Ixchelsis Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 15, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 20, 2020
• Results First Posted: August 20, 2020

Record last verified: 2020-08

Locations

GB (1)