Clinical trial NCT01209221: A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-27
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983
timeFrame: up to 240 hours
measure: Single ascending dose (SAD): Safety (incidence of adverse events)
timeFrame: 14 weeks
measure: Single ascending dose (SAD): Tolerability (e.g. vital signs)
timeFrame: 14 weeks
measure: Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983
timeFrame: 17 days
measure: Multiple ascending doses (MAD): Safety (incidence of adverse events)
timeFrame: 8 weeks
measure: Multiple ascending doses (MAD): Tolerability (e.g. vital signs)
timeFrame: 8 weeks
Secondary outcomes:
measure: Effect of food on pharmacokinetics of RO5271983
timeFrame: up to 240 hours
measure: Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983
timeFrame: 72 hours
measure: Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983
timeFrame: 14 days
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: