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NCT Number: NCT01631422

A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers

This single-center, open-label study will investigate the pharmacokinetics and elimination of a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers will receive a single oral dose of RO4602522.

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Key information

Conditions

Age range

35 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers, 35 to 55 years of age, inclusive
  • Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
  • A body mass index (BMI) between 18 to 30 kg/m2 inclusive
  • Male volunteers and their partners of childbearing potential must use 2 methods of contraception, one of which must be a barrier method for the duration of the study and for 90 days after the last dose.
  • Able to participate and willing to give written informed consent and to comply with the study restrictions.
  • Non-smokers or have not smoked since at least 3 months prior to screening

Exclusion criteria

  • If capable of reproduction, unwilling to use an effective form of contraception
  • Suspicion of regular consumption of drug of abuse and/or positive drug or alcohol screen
  • Infection with hepatitis B, hepatitis C, or human immunodeficiency virus 1 and 2
  • Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg
  • Resting pulse rate greater than 90 or less than 45 beats per minute
  • Clinically significant abnormalities in laboratory test results
  • Participation in an investigational drug or device study within 90 days prior to screening
  • Donation of blood within 3 months prior to screening
  • Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study

Treatment and study plan

RO4602522

Drug

Single radiolabeled dose

Primary outcomes

  1. Pharmacokinetics: Elimination of RO4602522: urine/feces concentration

    Time frame: Predose, Day 1, 2 and 3

  2. Pharmacokinetics: Plasma concentration of RO4602522/metabolite

    Time frame: Predose, Day 1, 2 and 3

Secondary outcomes

  1. Pharmacokinetics: Metabolic profile of RO4602522: plasma/urine/feces concentration

    Time frame: Predose, Day 1, 2 and 3

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Single-Center, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Radio-labeled RO4602522 in Healthy Male Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 29, 2012
Registry last updated
Nov 2, 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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