NCT01893437

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_1

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

June 27, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

June 27, 2013

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Part 1: Safety: Incidence of adverse events

    18 weeks

Secondary Outcomes (1)

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

    Pre-dose, Day 1, 2, 3, 4

Study Arms (1)

Single oral dose group

EXPERIMENTAL
Drug: RO6799477

Interventions

RO6799477DRUG

Single doses of RO6799477

Single oral dose group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Leiden, 2333, Netherlands

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

June 27, 2013

First Posted

July 9, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

NL(1)