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A Study of The Effects of Multiple Doses of Ketoconazole on Single Dose Pharmacokinetics of RO4602522 in Healthy Male Volunteers

NCT01625806 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-11-02

No results posted yet for this study

Summary

This single-center, open-label, parallel group study will evaluate the effects of multiple doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours) from Day 1 to Day 17.

Conditions

  • Healthy Volunteer

Interventions

DRUG

RO4602522

Single oral dose

DRUG

ketoconazole

Multiple oral doses

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01625806 on ClinicalTrials.gov