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

Healthy Volunteer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981005
• Other study ID #: NP28989
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2013
• Last updated: November 1, 2016
• Start date: November 2013
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO5424802
Single oral doses followed by IV or oral administration of a 14C-labeled tracer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elimination: Amount of drug excreted in urine/feces over the study period		Days 11 to 15	No
Primary	Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802		Days 1 to 25	No
Secondary	Safety: Incidence of adverse events		Days 1 to 25	No
Secondary	Pharmacokinetics: Metabolite identification in plasma, urine, and feces.		Days 11 to 25	No