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

Healthy Volunteer Clinical Trial

Official title:

A Single-Center, Open-Label, Single Oral Dose Phase I Study to Determine the Excretion Balance of Radiocarbon (i.e., the Sum of 14C-Labeled TRO19622 and Its 14C-Metabolites) and to Investigate the Pharmacokinetics and Metabolic Profile of TRO19622

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835976
• Other study ID #: WP29867
• Secondary ID: 2014-002470-37
• Status: Completed
• Phase: Phase 1
• First received: July 14, 2016
• Last updated: July 14, 2016
• Start date: July 2014
• Est. completion date: September 2014

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Trophos SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T1/2 of Radiocarbon		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	No
Primary	Apparent Plasma Clearance (CL/F) of Olesoxime and Any Major Metabolite(s) Identified		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	No
Primary	CL/F of Radiocarbon		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	No
Primary	Apparent Volume of Distribution (Vz/F) of Olesoxime and Any Major Metabolite(s) Identified		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	No
Primary	Vz/F of Radiocarbon		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	No
Primary	Cumulative Amount of Olesoxime Excreted in Urine		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	No
Primary	Cumulative Amount of Olesoxime Excreted in Expired Air		Pre-dose (0 h) and post-dose (8, 10, 12, 16, 24, 48, 72, 96 h) following single dose on Day 1	No
Primary	Cumulative Amount of Olesoxime Excreted in Feces		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	No
Primary	Renal Clearance (CLr) of Olesoxime		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	No
Primary	AUClast of Radiocarbon		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	No
Primary	AUCinf of Radiocarbon		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	No
Primary	Percentage of Participants with Adverse Events (AEs)		Continuously from Screening until 7 days after last dose (up to 46 days overall)	No
Primary	Maximum Observed Concentration (Cmax) of Olesoxime and Any Major Metabolite(s) Identified		Pre-dose (0 hours [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	No
Primary	Cmax of Radiocarbon		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	No
Primary	Time of Maximum Observed Concentration (Tmax) of Olesoxime and Any Major Metabolite(s) Identified		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	No
Primary	Tmax of Radiocarbon		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	No
Primary	Area Under the Concentration-Time Curve from Drug Administration to Last Quantifiable Concentration (AUClast) of Olesoxime and Any Major Metabolite(s) Identified		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	No
Primary	Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Olesoxime and Any Major Metabolite(s) Identified		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	No
Primary	Elimination Half-Life (t1/2) of Olesoxime and Any Major Metabolite(s) Identified		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	No