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Completed

NCT Number: NCT02835976

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

55 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olesoxime

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.

Other names: TRO19622

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Renal Clearance (CLr) of Olesoxime

    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

  10. AUClast 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

  11. AUCinf 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

  12. Percentage of Participants with Adverse Events (AEs)

    Time frame: Continuously from Screening until 7 days after last dose (up to 46 days overall)

  13. Maximum Observed Concentration (Cmax) of Olesoxime and Any Major Metabolite(s) Identified

    Time frame: 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

  14. Cmax 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

  15. Time of Maximum Observed Concentration (Tmax) 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

  16. Tmax 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

  17. Area Under the Concentration-Time Curve from Drug Administration to Last Quantifiable Concentration (AUClast) 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

  18. Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) 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

  19. Elimination Half-Life (t1/2) 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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Trophos SA

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 18, 2016
Registry last updated
Jul 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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