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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: placebo; Drug: bitopertin

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; Single oral dose
Experimental: Bitopertin	Drug: bitopertin; Single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	17 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 6, 2012
• First Posted (Estimate): July 10, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BP19292