Skip to main content
OpenTrials
Completed

NCT Number: NCT01209221

A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers

This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983 or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks for the SAD part and up to 8 weeks for the MAD part.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

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

  • Healthy volunteers, 18-65 years of age
  • Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
  • In the SAD, females subjects must be surgically sterile or post-menopausal for the past year; in the MAD females may be of child-bearing potential but must use 2 methods of highly effective contraception

Exclusion criteria

  • A history of clinically relevant cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, allergic or skin disease
  • Clinical significant abnormalities in laboratory test results
  • Symptoms of an infectious disease including upper respiratory tract infection within one month of study start or a history of recurrent infections
  • Smokers of >5 cigarettes/day within 3 months prior to admission and unable to stop smoking during study

Treatment and study plan

Placebo - MAD

Drug

Once or twice daily doses of matching placebo to RO5271983 for 14 days

Placebo - SAD

Drug

Single dose of matching placebo to RO5271983 for up to 3 periods

RO5271983 - MAD

Drug

Once or twice daily doses of RO5271983 for 14 days

RO5271983 - SAD

Drug

Single dose of RO5271983 at each period (for up to 3 periods)

Primary outcomes

  1. Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983

    Time frame: up to 240 hours

  2. Single ascending dose (SAD): Safety (incidence of adverse events)

    Time frame: 14 weeks

  3. Single ascending dose (SAD): Tolerability (e.g. vital signs)

    Time frame: 14 weeks

  4. Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983

    Time frame: 17 days

  5. Multiple ascending doses (MAD): Safety (incidence of adverse events)

    Time frame: 8 weeks

  6. Multiple ascending doses (MAD): Tolerability (e.g. vital signs)

    Time frame: 8 weeks

Secondary outcomes

  1. Effect of food on pharmacokinetics of RO5271983

    Time frame: up to 240 hours

  2. Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983

    Time frame: 72 hours

  3. Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase 1 Placebo-controlled, Randomized, Observer-blind Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5271983 in Healthy Subjects.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 27, 2010
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.