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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Olesoxime

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02835976

WP29867

2014-002470-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 55 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Olesoxime

Experimental group

Description:

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).

Treatment:

Drug: Olesoxime