A Study of the Effect of Fluvoxamine 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 Fluvoxamine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects

This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine 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 fluvoxamine 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: Fluvoxamine

• 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: No
• 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: Fluvoxamine; Multiple doses of fluvoxamine

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 26

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: incidence of adverse events	9 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: August 13, 2012
• First Submitted That Met QC Criteria: August 13, 2012
• First Posted (Estimate): August 15, 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; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluvoxamine
• Other Study ID Numbers: BP28250; 2012-000772-42 (EudraCT Number)