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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625806
• Other study ID #: BP28236
• Secondary ID: 2012-001195-11
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2012
• Last updated: November 1, 2016
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4602522
Single oral dose
• ketoconazole
Multiple oral doses

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	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	No
Secondary	Safety: Incidence of adverse events		approximately 3 months	No
Secondary	RO4602522 metabolites: Plasma/urine concentrations		Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22	No