A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

Healthy Volunteer Clinical Trial

Official title:

A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510899
• Other study ID #: BP25261
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2012
• Last updated: November 1, 2016
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer
• Renal Insufficiency

Intervention

Drug:
• RO4917838
Single dose of RO4917838
• RO4917838
Single dose of RO4917838

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

France,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area under concentration time curve of RO4917838		Days 1-16	No
Secondary	Safety: Incidence of adverse events		9 weeks	No