A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: bitopertin

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01636492

BP19292

Details and patient eligibility

About

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.

Enrollment

71 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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