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: July 7, 2014
Last verified: July 2014
  Purpose

This randomized, double-blind, placebo-controlled, dose-escalating study will ev aluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitope rtin in healthy male volunteers. Subjects will be randomized in cohorts to recei ve single oral doses of either bitopertin or placebo.


Condition Intervention Phase
Healthy Volunteer
Drug: bitopertin
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Single Oral Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4917838 in Healthy Male Volunteers.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 71
Study Start Date: November 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bitopertin Drug: bitopertin
Single oral dose
Placebo Comparator: Placebo Drug: placebo
Single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636492

Locations
New Zealand
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01636492     History of Changes
Other Study ID Numbers: BP19292
Study First Received: July 6, 2012
Last Updated: July 7, 2014
Health Authority: New Zealand: Ministry of Health

ClinicalTrials.gov processed this record on July 29, 2014