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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Placebo - MAD
* Drug: Placebo - SAD
* Drug: RO5271983 - MAD
* Drug: RO5271983 - SAD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |