A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01636492
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

July 6, 2012
July 10, 2012
November 2, 2016
November 2005
August 2006   (Final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: 17 days ]
Same as current
Complete list of historical versions of study NCT01636492 on Archive Site
  • 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 ]
  • Pharmacokinetics: Urine concentrations drug/metabolites [ Time Frame: Pre-dose and up to 72 hours post-dose ]
Same as current
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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
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
New Zealand
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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