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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01209221

Enrollment

Registered

2010-09-27

Start date

2010-09-30

Completion date

2011-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGPlacebo - MAD

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

DRUGPlacebo - SAD

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

DRUGRO5271983 - MAD

Once or twice daily doses of RO5271983 for 14 days

DRUGRO5271983 - SAD

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026