A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

Healthy Volunteer Clinical Trial

Official title:

Single Oral Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4917838 in Healthy Male Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636492
• Other study ID #: BP19292
• Status: Completed
• Phase: Phase 1
• First received: July 6, 2012
• Last updated: November 1, 2016
• Start date: November 2005
• Est. completion date: August 2006

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• bitopertin
Single oral dose
• placebo
Single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		17 days	No
Secondary	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	No
Secondary	Pharmacokinetics: Urine concentrations drug/metabolites		Pre-dose and up to 72 hours post-dose	No