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A Study of RO6799477 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01893437
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This single-center, randomized, double-blind, placebo-controlled, single dose study will investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO6799477 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6799477 Following Oral Administration of Single Ascending Doses in Healthy Volunteers.
Study Start Date : July 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Single oral dose group Drug: RO6799477
Single doses of RO6799477




Primary Outcome Measures :
  1. Part 1: Safety: Incidence of adverse events [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Part 1 and 2: Pharmacokinetics: plasma concentration of RO6799477 [ Time Frame: Pre-dose, Day 1, 2, 3, 4 ]


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:

  • Male healthy volunteers, aged 18-45 years, inclusive
  • Male volunteers with female partner of childbearing potential must agree to use an effective form of birth control during the study and for 3 months after discontinuation of treatment.
  • Body Mass index (BMI) of 18-30 kg/m2, inclusive

Exclusion Criteria:

  • Infection with human immunodeficiency virus antibody (HIV 1 and 2), Hepatitis B, hepatitis C
  • Positive testing for drugs of abuse
  • Any history of alcohol and/or drug of abuse addiction

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): NCT01893437


Locations
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Netherlands
Leiden, Netherlands, 2333
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: NCT01893437     History of Changes
Other Study ID Numbers: BP28751
2013-000402-28 ( EudraCT Number )
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016