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

Hoffmann-La Roche6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer

Interventions

OlesoximeDRUG

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

Eligibility

Sex: MALEMin age: 55 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

T1/2 of Radiocarbon

Time frame: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1

Apparent Plasma Clearance (CL/F) of Olesoxime and Any Major Metabolite(s) Identified

Time frame: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1

CL/F of Radiocarbon

Time frame: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1

Apparent Volume of Distribution (Vz/F) of Olesoxime and Any Major Metabolite(s) Identified

Time frame: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1

Vz/F of Radiocarbon

Time frame: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1

Cumulative Amount of Olesoxime Excreted in Urine

Time frame: Continuous urine collection from pre-dose (0 h) to post-dose (432 h, or until release criteria are met) following single dose on Day 1

Cumulative Amount of Olesoxime Excreted in Expired Air

Time frame: Pre-dose (0 h) and post-dose (8, 10, 12, 16, 24, 48, 72, 96 h) following single dose on Day 1

Cumulative Amount of Olesoxime Excreted in Feces

Time frame: Continuous fecal collection from pre-dose (0 h) to post-dose (432 h, or until release criteria are met) following single dose on Day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.