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A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01367756
First received: May 30, 2011
Last updated: November 3, 2014
Last verified: November 2014

May 30, 2011
November 3, 2014
May 2011
September 2011   (final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: up to 58 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01367756 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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 tol erability of RO4995819 in combination with citalopram in healthy volunteers. Sub jects will receive citalopram orally on Days 1-9 and be randomized to receive ei ther RO4995819 orally or placebo in combination with citalopram on Days 10-16. S afety follow-up will be up to Day 58.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Healthy Volunteer
  • Drug: citalopram
    multiple oral doses, Days 1-16
  • Drug: placebo
    multiple oral doses, Days 10-16
  • Drug: RO4995819
    multiple oral doses, Days 10-16
  • Experimental: 1
    Interventions:
    • Drug: citalopram
    • Drug: RO4995819
  • Placebo Comparator: 2
    Interventions:
    • Drug: citalopram
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01367756
BP25679
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP