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OpenTrials
Completed

NCT Number: NCT01981005

A Study of the Elimination, Pharmacokinetics, and Metabolism of RO5424802

This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802 and the pharmacokinetics of a 14C-labeled tracer in healthy volunteers

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Key information

Conditions

Age range

18 year–45 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

  • Male adults, 18 to 45 years of age, inclusive
  • Body mass index (BMI) from 18 to 32 kg/m2, inclusive
  • Willingness to use effective contraception as outlined in the protocol
  • Willingness to abstain from alcohol and xanthine-containing beverages or food (coffee, tea, cola, chocolate and "energy drinks") from 72 hours prior to the first dose until discharged
  • Willingness to avoid prolonged sun exposure and guard against sunburn during study & follow-up

Exclusion criteria

  • Clinically significant medical history or findings in physical examination, vital signs, or laboratory test results prior to study start
  • Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse, or tobacco
  • Regular smoking within 6 months prior to first dosing. Subjects should avoid smoky environments for at least 1 week prior to each cotinine screen
  • Excessive alcohol consumption
  • Use of any metabolic inducers (including herbals such as St. John's Wort) within 4 weeks or 5 half-lives (whichever is longer) before the first dose of study medication, including but not limited to: rifampin, rifabutin, glucocorticoids, carbamazepine, phenytoin and phenobarbital
  • Regular work with ionizing radiation or radioactive material
  • Subjects enrolled in a previous radiolabel study or who have received radiotherapy within 12 months prior to first dosing such that total radioactivity over a 12 month period would exceed an acceptable radiation burden > 0.1 mSv
  • Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work or participation in a medical trial in the previous year
  • Strenuous activity, sunbathing, or contact sports are not allowed from 4 days prior to entry into the clinical site until study follow-up
  • Participation in an investigational drug or device study within 60 days (or 6 months for biologic therapies) prior to first dosing

Treatment and study plan

RO5424802

Drug

Single oral doses followed by IV or oral administration of a 14C-labeled tracer

Primary outcomes

  1. Elimination: Amount of drug excreted in urine/feces over the study period

    Time frame: Days 11 to 15

  2. Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802

    Time frame: Days 1 to 25

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: Days 1 to 25

  2. Pharmacokinetics: Metabolite identification in plasma, urine, and feces.

    Time frame: Days 11 to 25

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A PHASE 1, SINGLE-CENTER, OPEN-LABEL STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS AND METABOLISM OF A SINGLE ORAL DOSE AND PHARMACOKINETICS OF AN INTRAVENOUS TRACER OF [14-C]-RO5424802 IN HEALTHY MALE SUBJECTS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 11, 2013
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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