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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01510899
• Date of registration: 12/01/2012
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
• Scientific title: A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
• Date of first enrolment: October 2011
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01510899
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

France, Russian Federation

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteer

Intervention(s)

Drug: RO4917838

Primary Outcome(s)

Pharmacokinetics: Area under concentration time curve of RO4917838 [Time Frame: Days 1-16]

Secondary Outcome(s)

Safety: Incidence of adverse events [Time Frame: 9 weeks]

Secondary ID(s)

BP25261

Source(s) of Monetary Support

Please refer to primary and secondary sponsors