A Study of RO6799477 in Healthy Volunteers

November 1, 2016 updated by: Hoffmann-La Roche

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single oral dose group
Drug: RO6799477
Single doses of RO6799477

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1: Safety: Incidence of adverse events
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Part 1 and 2: Pharmacokinetics: plasma concentration of RO6799477
Time Frame: Pre-dose, Day 1, 2, 3, 4
Pre-dose, Day 1, 2, 3, 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (Estimate)

July 9, 2013

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • BP28751
  • 2013-000402-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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