A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

NCT01636492 | Completed Phase 1

• 1 other identifier: BP19292
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of adverse events

  17 days

Secondary Outcomes (2)

• 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

Study Arms (2)

Bitopertin

EXPERIMENTAL

Drug: bitopertin

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

bitopertin DRUG

Single oral dose

Bitopertin

placebo DRUG

Single oral dose

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Christchurch, 8011, New Zealand

Location

MeSH Terms

Interventions

(4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl)(5-methanesulfonyl-2-(2,2,2-trifluoro-1-methylethoxy)phenyl)methanone

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 10, 2012
• Study Start: November 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NZ (1)