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A Study of RO6926496 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281786
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a single center, randomized, investigator/subject blind, single ascending dose, placebo-controlled, parallel study that will evaluate the safety, tolerability and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration of the study is 16 weeks.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Placebo Drug: RO6926496 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: Cohort 1
8 volunteers (6 active, 2 placebo)
Drug: Placebo
Matching placebo to RO6926496

Drug: RO6926496
single, ascending dose, intravenous administration

Experimental: Cohort 2
8 volunteers (6 active, 2 placebo)
Drug: Placebo
Matching placebo to RO6926496

Drug: RO6926496
single, ascending dose, intravenous administration

Experimental: Cohort 3
8 volunteers (6 active, 2 placebo)
Drug: Placebo
Matching placebo to RO6926496

Drug: RO6926496
single, ascending dose, intravenous administration

Experimental: Cohort 4
8 volunteers (6 active, 2 placebo)
Drug: Placebo
Matching placebo to RO6926496

Drug: RO6926496
single, ascending dose, intravenous administration

Experimental: Cohort 5
8 volunteers (6 active, 2 placebo)
Drug: Placebo
Matching placebo to RO6926496

Drug: RO6926496
single, ascending dose, intravenous administration

Experimental: Cohort 6
8 volunteers (6 active, 2 placebo)
Drug: Placebo
Matching placebo to RO6926496

Drug: RO6926496
single, ascending dose, intravenous administration




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Up to 16 weeks ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281786


Locations
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United Kingdom
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02281786    
Other Study ID Numbers: BP29462
2014-003170-16 ( EudraCT Number )
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016