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

November 1, 2016 updated by: Hoffmann-La Roche

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: RO5271983 - SAD
Single dose of RO5271983 at each period (for up to 3 periods)
Experimental: 2
Drug: RO5271983 - MAD
Once or twice daily doses of RO5271983 for 14 days
Placebo Comparator: 4
Drug: Placebo - MAD
Once or twice daily doses of matching placebo to RO5271983 for 14 days
Placebo Comparator: 3
Drug: Placebo - SAD
Single dose of matching placebo to RO5271983 for up to 3 periods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983
Time Frame: up to 240 hours
up to 240 hours
Single ascending dose (SAD): Safety (incidence of adverse events)
Time Frame: 14 weeks
14 weeks
Single ascending dose (SAD): Tolerability (e.g. vital signs)
Time Frame: 14 weeks
14 weeks
Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983
Time Frame: 17 days
17 days
Multiple ascending doses (MAD): Safety (incidence of adverse events)
Time Frame: 8 weeks
8 weeks
Multiple ascending doses (MAD): Tolerability (e.g. vital signs)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of food on pharmacokinetics of RO5271983
Time Frame: up to 240 hours
up to 240 hours
Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983
Time Frame: 72 hours
72 hours
Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 24, 2010

First Submitted That Met QC Criteria

September 24, 2010

First Posted (Estimate)

September 27, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • NP25342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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