A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: bitopertin; Drug: placebo

• Registration Number: NCT01636492
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bitopertin	bitopertin	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	17 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area under the concentration-time curve	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	Pre-dose and up to 72 hours post-dose