A Study of the Excretion Balance of Radiocarbon and the Pharmacokinetics and Metabolic Profile of TRO19622 (Olesoxime)

NCT ID: NCT02835976

Last Updated: 2016-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-09-30

Brief Summary

This Phase I study is designed to determine the excretion balance of radiocarbon, as the sum of carbon-14 (14C)-labeled TRO19622 and its 14C-metabolites, and to investigate the pharmacokinetics and metabolic profile of TRO19622 (olesoxime) in healthy participants.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Olesoxime

Participants will receive a single dose of liquid suspension of 14C-labeled olesoxime containing an equivalent of 600 milligrams (mg) of the compound. The total amount of administered radiocarbon will be 93 microcuries (mcCi), or 3.447 megabecquerels (MBq).

Group Type: EXPERIMENTAL

Olesoxime

Intervention Type: DRUG

Olesoxime will be given orally on Day 1 as a 600-mg liquid suspension within 30 minutes after starting a standardized high-fat breakfast.

Interventions

Olesoxime

Olesoxime will be given orally on Day 1 as a 600-mg liquid suspension within 30 minutes after starting a standardized high-fat breakfast.

Intervention Type: DRUG

Other Intervention Names

TRO19622

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) 20.0 to 28.0 kilograms per meter-squared (kg/m^2) and body weight at least 60 kilograms (kg)
• Fitzpatrick skin type less than (<) 4
• Good health according to medical history, physical examination, laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG)
• Negative urine test for drugs of abuse
• Negative alcohol breath test
• Negative tests for hepatitis or human immunodeficiency virus (HIV)
• Use of effective contraception during and for 3 months beyond study participant, among sexually active non-vasectomized participants with females partners of childbearing potential

Exclusion Criteria

• Concomitant or recent medication use within 2 weeks prior to Day 1, except for paracetamol
• Use of enzyme-inducing drugs within 2 months prior to Day 1
• Any medical condition that may alter the pharmacokinetics of olesoxime or affect interpretation of study results
• Irregular bowel movements
• Drug addiction or alcoholism
• Use of nicotine products
• Participation in another clinical study within 12 weeks prior to Day 1
• Exposure to ionizing radiation within one year prior to Day 1

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Trophos SA

UNKNOWN

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Other Identifiers

2014-002470-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WP29867

Identifier Type: -

Identifier Source: org_study_id