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A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01367756
First received: May 30, 2011
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

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: placebo
Drug: citalopram
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: up to 58 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram [ Time Frame: 17 days ] [ Designated as safety issue: No ]
  • Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram [ Time Frame: up to 58 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (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: placebo
multiple oral doses, Days 10-16
Drug: citalopram
multiple oral doses, Days 1-16

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367756

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

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01367756     History of Changes
Other Study ID Numbers: BP25679
Study First Received: May 30, 2011
Last Updated: February 15, 2012
Health Authority: France: Agence Francaise de Securite Sanitaire des produits de Sante

Additional relevant MeSH terms:
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 22, 2013