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Completed

NCT Number: NCT01636492

A Study of Bitopertin (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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Christchurch, 8011, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bitopertin

Drug

Single oral dose

Placebo

Drug

Single oral dose

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 17 days

Secondary outcomes

  1. Pharmacokinetics: Area under the concentration-time curve

    Time frame: Pre-dose and 1, 2, 4, 8, 12, 24, 72, 96, 144, 168 (+/-8), 216 (+/-24), 288 (1/-48) hours post-dose

  2. Pharmacokinetics: Urine concentrations drug/metabolites

    Time frame: Pre-dose and up to 72 hours post-dose

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 10, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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