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A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01636492
First received: July 6, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted

July 6, 2012
July 6, 2012
November 2005
August 2006   (final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Pre-dose and 1, 2, 4, 8, 12, 24, 72, 96, 144, 168 (+/-8), 216 (+/-24), 288 (1/-48) hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Urine concentrations drug/metabolites [ Time Frame: Pre-dose and up to 72 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Bitopertin (RO4917838) in Healthy Male Volunteers
Single Oral Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4917838 in Healthy Male Volunteers.

This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Healthy Volunteer
  • Drug: bitopertin
    Single oral dose
  • Drug: placebo
    Single oral dose
  • Experimental: Bitopertin
    Intervention: Drug: bitopertin
  • Placebo Comparator: Placebo
    Intervention: 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
71
August 2006
August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male healthy volunteer, 18 to 60 years of age inclusive
  • Body mass index (BMI) 19-35 kg/m2 inclusive
  • Supine blood pressure within the normal range of the center and heart rate >/= 40 provided QTcB is <450 ms
  • Subjects must agree to use a barrier method of contraception (e.g. condom) for the duration of the study and for 30 days after study completion

Exclusion Criteria:

  • History or evidence of any clinically significant disease or disorder
  • Clinically significant ECG abnormalities
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Previous treatment with iron for iron deficiency anemia
  • Regular smoker (>10 cigarettes, >3 pipefuls or >3 cigars per day)
  • History of alcohol and/or drug abuse or addiction within the last 2 years before study start
  • Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
  • Participation in a clinical study with an investigational drug within the last three months prior to screening
  • Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigators or their designee
Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT01636492
BP19292
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2012

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