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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01625806

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: RO4602522 Drug: ketoconazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

A Single-Center, Open-Label, Parallel Study to Investigate the Effects of Multiple Doses of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of RO4602522 in Healthy Male Subjects

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RO4602522	Drug: RO4602522 Single oral dose
Experimental: RO4602522 + ketoconazole	Drug: RO4602522 Single oral dose Drug: ketoconazole Multiple oral doses

Arm

Intervention/Treatment

Active Comparator: RO4602522

Drug: RO4602522

Single oral dose

Experimental: RO4602522 + ketoconazole

Drug: RO4602522

Single oral dose

Drug: ketoconazole

Multiple oral doses

Outcome Measures

Primary Outcome Measures

Effect of multiple doses of ketoconazole on RO4602522 single dose pharmacokinetics: Area under the concentration-time curve (AUC) [Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22]

Secondary Outcome Measures

Safety: Incidence of adverse events [approximately 3 months]
RO4602522 metabolites: Plasma/urine concentrations [Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male subjects, 18 to 45 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
Body mass index (BMI) 18 to 30 kg/m2 inclusive
Male subjects and their partners of child-bearing potential must use two 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
Non-smoker (not having smoked since at least 3 months prior to screening)

Exclusion Criteria:

History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
Positive for hepatitis B, hepatitis C, or HIV infection
Participation in an investigational drug or device study within 90 days 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
History of any disease or condition that could alter the absorption, metabolism or elimination of drugs
Positive drug test and/or positive alcohol test
Positive cotinine test
Subject likely to need concomitant medication during the study period (including for dental conditions)
Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Zuidlaren		Netherlands	9471 GP

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01625806

Other Study ID Numbers:

BP28236
2012-001195-11

First Posted:

Jun 21, 2012

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Ketoconazole

Study Results

No Results Posted as of Nov 2, 2016