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CompletedNCT01398241Updated Nov 2, 2016

A Study of RO5267683 in Healthy Subjects

A Phase 1 interventional study of RO5267683 and placebo in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Active

    Drug: RO5267683

  • Placebo comparator
    Placebo

    Drug: placebo

Interventions

  • DrugRO5267683

    Multiple ascending doses

  • Drugplacebo

    Multiple ascending doses

06

What researchers measure

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

07

Study locations

1 site
  • Strasbourg, 67064, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01398241
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jul 20, 2011
Start date
Aug 2011
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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