NCT01510899

Brief Summary

This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_1

Geographic Reach
2 countries

3 active sites

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

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

January 12, 2012

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics: Area under concentration time curve of RO4917838

    Days 1-16

Secondary Outcomes (1)

  • Safety: Incidence of adverse events

    9 weeks

Study Arms (2)

Healthy Subjects Arm

EXPERIMENTAL
Drug: RO4917838

Renal Impaired Subjects Arm

EXPERIMENTAL
Drug: RO4917838

Interventions

RO4917838DRUG

Single dose of RO4917838

Renal Impaired Subjects Arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • General criteria
  • Body mass index (BMI) between 18 and 32 kg/m2
  • Criteria applying to renal impaired subjects
  • Adult subjects, 18-65 years of age
  • Part 1: Subjects with end stage renal disease (ESRD), not on dialysis
  • Part 2: Subjects with severe, moderate or mild renal impairment
  • Stable renal function
  • Criteria applying to healthy subjects
  • Adult subjects, 18-70 years of age

You may not qualify if:

  • General criteria
  • Any condition or disease (other than renal impairment for the renal impaired subjects only) that would render the subject unsuitable for the study, or would place the subject at undue risk
  • Any condition which could relapse during or immediately after the study
  • History of alcohol or drug abuse
  • Criteria applying to renal impaired subjects
  • Evidence of unstable clinically significant disease other than renal impairment
  • Clinically significant liver disease
  • Any other major illness (with the exception of renal impairment) within 4 weeks prior to study start
  • Criteria applying to healthy subjects
  • History of any clinically significant disease (e.g., cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Rennes, 35042, France

Location

Unknown Facility

Moscow, 117192, Russia

Location

Unknown Facility

Moscow, 117292, Russia

Location

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 18, 2012

Study Start

October 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

RU(2)FR(1)