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Completed

NCT Number: NCT01398241

A Study of RO5267683 in Healthy Subjects

This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Strasbourg, 67064, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female subjects, 18 to 45 years of age,
  • Body mass index (BMI) 18 to 30 kg/m2 inclusive, and a minimum weight of 50 kg at screening
  • Female subjects must be surgically sterile or post-menopausal
  • Male subjects must use a barrier method of contraception for the duration of the study and for 90 days after the last dose

Exclusion criteria

  • History or evidence of any clinically significant disease or disorder
  • Administration of an investigational drug or device within 3 months prior to dosing on Day 1
  • Positive for hepatitis B, hepatitis C or HIV at screening
  • Subjects on hormone replacement therapy who have not been receiving a stable dose for at least 2 months prior to start of dosing

Treatment and study plan

RO5267683

Drug

Multiple ascending doses

Placebo

Drug

Multiple ascending doses

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 14 weeks

Secondary outcomes

  1. Pharmacokinetics: Plasma concentrations

    Time frame: 14 weeks

  2. Pharmacokinetics: Urine concentrations

    Time frame: 4 weeks

  3. Lipid levels in the blood

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5267683 in an Adaptive, Randomized, Investigator-blind and Subject-blind, Multiple-ascending Dose, Placebo-controlled, Study Following Oral Administrations in Healthy Subjects for 28 Days

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2011
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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