A Study of RO6926496 in Healthy Volunteers | RxWiki

A Study of RO6926496 in Healthy Volunteers

Overview[ - collapse ][ - ]

Purpose	This is a single center, randomized, investigator/subject blind, single ascendin g dose, placebo-controlled, parallel study that will evaluate the safety, tolera bility and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. It is planned to enroll 48 subjects in 6 cohor ts. The anticipated total duration of the study is 16 weeks.
Condition	Healthy Volunteer
Intervention	Drug: Placebo Drug: RO6926496
Phase	Phase 1
Sponsor	Hoffmann-La Roche
Responsible Party	Hoffmann-La Roche
ClinicalTrials.gov Identifier	NCT02281786
First Received	October 30, 2014
Last Updated	January 6, 2015
Last verified	January 2015

Tracking Information[ + expand ][ + ]

First Received Date	October 30, 2014
Last Updated Date	January 6, 2015
Start Date	December 2014
Estimated Primary Completion Date	November 2015
Current Primary Outcome Measures	Incidence of adverse events (AEs) [Time Frame: Up to 16 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	Pharmacokinetic profile and parameters derived from serum concentrations of RO6926496 (composite outcome measure): area under the concentration-time curve (AUC), Cmax, tmax, clearance [Time Frame: Up to 16 weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Study of RO6926496 in Healthy Volunteers
Official Title	A SINGLE-CENTER, RANDOMIZED, INVESTIGATOR/SUBJECT BLIND, SINGLE ASCENDING DOSE, PLACEBO CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF RO6926496 FOLLOWING INTRAVENOUS INFUSION IN HEALTHY SUBJECTS
Brief Summary	This is a single center, randomized, investigator/subject blind, single ascendin g dose, placebo-controlled, parallel study that will evaluate the safety, tolera bility and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. It is planned to enroll 48 subjects in 6 cohor ts. The anticipated total duration of the study is 16 weeks.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Condition	Healthy Volunteer
Intervention	Drug: Placebo Matching placebo to RO6926496 Drug: RO6926496 single, ascending dose, intravenous administration
Study Arm (s)	Experimental: Cohort 1 8 volunteers (6 active, 2 placebo) Experimental: Cohort 2 8 volunteers (6 active, 2 placebo) Experimental: Cohort 3 8 volunteers (6 active, 2 placebo) Experimental: Cohort 4 8 volunteers (6 active, 2 placebo) Experimental: Cohort 5 8 volunteers (6 active, 2 placebo) Experimental: Cohort 6 8 volunteers (6 active, 2 placebo)

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	48
Estimated Completion Date	November 2015
Estimated Primary Completion Date	November 2015
Eligibility Criteria	Inclusion Criteria: - Healthy male participants, 18 to 45 years of age; healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history - A body mass index between 18 and 30 kg/m2 - Male subjects and their partners of childbearing potential must agree to use 2 methods of contraception, one of which must be a barrier method for the duration of the study Exclusion Criteria: - Positive hepatitis B, hepatitis C, or HIV infection - History of any clinically significant disease or disorder - Clinically significant abnormalities in laboratory test results - Participation in an investigational drug or device study within 90 days prior to screening - Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study - History or presence of clinically significant ECG abnormalities - Smokers who smoke more than 10 cigarettes daily or equivalent and unable or unwilling not to smoke during the in-clinic period - Any clinically relevant history of hypersensitivity or allergic reactions - Any familial history of early onset Alzheimer's disease
Gender	Male
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Contact: Reference Study ID Number: BP29462 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
Location Countries	United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number	NCT02281786
Other Study ID Numbers	BP29462
Has Data Monitoring Committee	Not Provided
Information Provided By	Hoffmann-La Roche
Study Sponsor	Hoffmann-La Roche
Collaborators	Not Provided
Investigators	Study Director: Clinical Trials Hoffmann-La Roche
Verification Date	January 2015

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