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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo - MAD; Drug: RO5271983 - SAD; Drug: Placebo - SAD; Drug: RO5271983 - MAD

• Registration Number: NCT01209221
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-24
• Study First Submitted QC: 2010-09-24
• Study First Posted: 2010-09-27
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	Placebo - MAD	-
1	RO5271983 - SAD	-
3	Placebo - SAD	-
2	RO5271983 - MAD	-

Primary Outcome Measures

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

Secondary Outcome Measures

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