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Completed

NCT Number: NCT01864226

A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers

This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be randomized to receive either RO5545965 or matching placebo daily for 12 days.

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult male and female volunteers, 18 - 64 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
  • Body mass index (BMI) 18 to 30 kg/m2 inclusive
  • Female subject must be post-menopausal or surgically sterile
  • Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for at least 30 days after the last dose of study drug

Exclusion criteria

  • History of any clinically significant disease or disorder
  • Concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  • Clinically significant abnormalities in laboratory test results
  • Suspicion of regular consumption of drug of abuse
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Participation in an investigational drug or device study within 90 days prior to screening
  • Regular smoker (>5 cigarettes, >1 pipeful or >1 cigar per day)
  • History of clinically significant hypersensitivity or allergic drug reactions

Treatment and study plan

RO5545965

Drug

Multiple ascending doses

Placebo

Drug

Multiple ascending doses

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 3 months

Secondary outcomes

  1. Pharmacokinetics: Area under the concentration-time curve (AUC)

    Time frame: 17 days

  2. Pharmacokinetics: Plasma concentrations

    Time frame: 17 days

  3. Pharmacokinetics: Urine concentrations

    Time frame: 13 days

  4. Pharmacodynamics: Serum prolactin levels

    Time frame: Day 12

  5. Pharmacodynamics: Glucose tolerance test

    Time frame: Day 11

  6. Pharmacodynamics: Probabilistic learning tasks

    Time frame: Days 6, 8 and 10

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Multiple Ascending-Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 Following Oral Administration in Healthy Subjects.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 29, 2013
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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