NCT01398241

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

July 14, 2011

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Safety: Incidence of adverse events

    14 weeks

Secondary Outcomes (3)

  • Pharmacokinetics: Plasma concentrations

    14 weeks

  • Pharmacokinetics: Urine concentrations

    4 weeks

  • Lipid levels in the blood

    14 weeks

Study Arms (2)

Active

EXPERIMENTAL
Drug: RO5267683

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

RO5267683DRUG

Multiple ascending doses

Active
placeboDRUG

Multiple ascending doses

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Strasbourg, 67064, France

Location

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 20, 2011

Study Start

August 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

FR(1)