A Study of Multiple Oral Doses of IX-01 in Healthy Male Subjects

NCT02792647 | Completed Phase 1

• 1 other identifier: IX-0104
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety and tolerability of IX-01 after multiple doses, and to determine the PK of IX-01 and activity of CYP3A4.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs

  Baseline to Day 20 (Estimated up to 3 weeks)

Secondary Outcomes (12)

• Peak Plasma Concentration (Cmax) of IX-01

  Pre-dose to 24 hours post dose on Days 1 and 10

• Area Under the Plasma Concentration-Time Curve (AUCtau)

  Pre-dose up to 24 hours post dose on Days 1 and 10

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

  Pre-dose to 24 hours post dose on Days 1 and 10

• Urine 6-β-hydroxycortisol/cortisol Ratio

  Pre-dose on Day 1 and Day 10

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

  Pre-dose up to 96 hours post dose on Day 10

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Experimental: IX-01

EXPERIMENTAL

2 different dose groups 1,600 mg and 2,400 mg of IX-01 oral aqueous dispersion, administered once daily for 10 days

Drug: IX-01

Interventions

Placebo DRUG

Administered orally

Placebo

IX-01 DRUG

Administered orally

Experimental: IX-01

Eligibility Criteria

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

You may qualify if:

• Male healthy volunteer.
• Aged 18-45 years at the time of signing the informed consent.
• A body mass index (Quetelet index) in the range 18-30.
• Total body weight \>50 kg at screening.
• Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
• Willingness to comply with the contraception requirements of the trial.
• Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.
• Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).

You may not qualify if:

• Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer, including any of the following findings:
• have 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
• history of unexplained syncope
• family history of unexplained sudden death, or sudden death due to long QT syndrome
• QTcF interval \>450 msec in 2 of 3 consecutive ECGs (additional ECGs may be recorded, if required, but a median QTcF ≤ 450 msec from 3 consecutive ECGs is required for the volunteer to be considered eligible)
• 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 the volunteer's participation in the trial or make it unnecessarily hazardous.
• 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 (e.g. stomach bypass) or medical condition that might affect absorption of medicines.
• 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 subject 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 3 months prior to the first dose.

Sponsors & Collaborators

• Ixchelsis Limited: lead

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Location

Study Officials

• Franz van den Berg, MBChB

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 7, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)