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

NCT01625806 | Completed Phase 1

• 2 other identifiers: BP282362012-001195-11
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

RO4602522

ACTIVE COMPARATOR

Drug: RO4602522

RO4602522 + ketoconazole

EXPERIMENTAL

Drug: RO4602522; Drug: ketoconazole

Interventions

RO4602522 DRUG

Single oral dose

RO4602522; RO4602522 + ketoconazole

ketoconazole DRUG

Multiple oral doses

RO4602522 + ketoconazole

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

MeSH Terms

Interventions

sembragiline; Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)