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OpenTrials
Completed

NCT Number: NCT01893437

A Study of RO6799477 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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Leiden, 2333, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO6799477

Drug

Single doses of RO6799477

Primary outcomes

  1. Part 1: Safety: Incidence of adverse events

    Time frame: 18 weeks

Secondary outcomes

  1. Part 1 and 2: Pharmacokinetics: plasma concentration of RO6799477

    Time frame: Pre-dose, Day 1, 2, 3, 4

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 9, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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