A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

A Single Center, Randomized, Double-blind, Parallel-design Study to Investigate the Safety and Tolerability of RO4995819 in Combination With Citalopram Following Oral Administration in Healthy Volunteers

This randomized, double-blind, parallel-arm study will assess the safety and tolerability of RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO4995819; Drug: citalopram; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67064

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:

• Adult healthy male or female subjects, 18 to 65 years of age inclusive (healthy status defined as absence of evidence of any active or chronic disease)
• Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
• Female subjects who are not either surgically sterile or post-menopausal must commit to using a barrier form of contraception in addition to either an intrauterine device or hormonal contraception until at least 5 months after the last dose of study drug
• Male subjects must use a barrier method of contraception throughout the study and for up to 5 months after the last dose of study drug (applies also to surgically sterilized males)
• Willing not to participate in any other clinical trial with an investigational drug for at least 5 months following the last dose of study drug

Exclusion Criteria:

• Pregnant or lactating females
• Suspicion of regular consumption of drug of abuse or positive test for alcohol on Day -2
• Hepatitis B, hepatitis C or HIV infection
• Smokers of >5 cigarettes or equivalent tobacco intake per day
• Any confirmed allergic reaction against any drug, or multiple allergies (non-active hay fever is acceptable)
• Participation in an investigational drug or device study within 3 months prior to dosing

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: RO4995819; multiple oral doses, Days 10-16; Drug: citalopram; multiple oral doses, Days 1-16
Placebo Comparator: 2	Drug: citalopram; multiple oral doses, Days 1-16; Drug: placebo; multiple oral doses, Days 10-16

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	up to 58 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram	17 days
Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram	up to 58 days

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: May 30, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimate): June 7, 2011

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; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: BP25679