A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects

This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a cross-over design. The anticipated time on study treatment is 40 days.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO4917523; Drug: Carbamazepine

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35042

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers, 18-65 years of age inclusive
• Non-smokers
• Body mass index (BMI) between 18 and 30 mg/m2 inclusive
• Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception

Exclusion Criteria:

• Evidence of any active or chronic disease
• History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer
• History or presence of clinically significant psychiatric condition
• Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dosing Period 1	Drug: RO4917523; Single dose of RO4917523
Experimental: Dosing Period 2	Drug: RO4917523; Single dose of RO4917523; Drug: Carbamazepine; Multiple doses of carbamazepine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Area under the concentration time curve	Period 1: Pre-dose and up to Day 14, Period 2: Pre-dose and up to Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: incidence of adverse events	6 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: June 25, 2012
• First Posted (Estimate): June 27, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Sodium Channel Blockers; Antimanic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Carbamazepine
• Other Study ID Numbers: BP28256; 2012-000771-16 (EudraCT Number)