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A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 30, 2011
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Healthy Volunteer Drug: RO4995819 Drug: citalopram Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: up to 58 days ]

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

Enrollment: 32
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01367756

Strasbourg, France, 67064
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01367756     History of Changes
Other Study ID Numbers: BP25679
Study First Received: May 30, 2011
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents processed this record on August 18, 2017