A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteer	Drug: RO5271983 - SAD Drug: RO5271983 - MAD Drug: Placebo - SAD Drug: Placebo - MAD	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983 [ Time Frame: up to 240 hours ] [ Designated as safety issue: No ]
Single ascending dose (SAD): Safety (incidence of adverse events) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Single ascending dose (SAD): Tolerability (e.g. vital signs) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983 [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Multiple ascending doses (MAD): Safety (incidence of adverse events) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Multiple ascending doses (MAD): Tolerability (e.g. vital signs) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of food on pharmacokinetics of RO5271983 [ Time Frame: up to 240 hours ] [ Designated as safety issue: No ]
Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment:	82
Study Start Date:	September 2010
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: 3	Drug: Placebo - SAD Single dose of matching placebo to RO5271983 for up to 3 periods
Placebo Comparator: 4	Drug: Placebo - MAD Once or twice daily doses of matching placebo to RO5271983 for 14 days

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209221

Locations

New Zealand

Christchurch, New Zealand, 8011

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01209221 History of Changes
Other Study ID Numbers:	NP25342
Study First Received:	September 24, 2010
Last Updated:	May 23, 2013
Health Authority:	New Zealand: Health and Disability Ethics Committees

ClinicalTrials.gov processed this record on May 23, 2013