A Study on the Effect of Renal Function on the Pharmacakokinetics of RO5024048 (Parent of Prodrug RO5024048) Following Multiple Oral Dose Administration of RO5024048

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

This open-label, parallel group study will evaluate the effect of renal function on the pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and assess the effect of renal impairment on safety and tolerability of RO5024048. Adult males or females with either normal renal function or mild or moderate renal impairment will receive RO5024048 orally for 5 days. Target sample size is \<50.

Key facts

Study ID: NCT01099904
Run by: Hoffmann-La Roche
People needed: 30
Starts: 2010-03-01
Expected to finish: 2010-09-01
Last updated by the study team: 2016-11-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

male or female adults, 18-75 years of age
normal, or mildly or moderately impaired renal function (creatinine clearance >/= 30 mL/min)
BMI 18-40 kg/m2
stable renal function
agree to abstain from alcohol consumption during study drug adminsitration and limit consumption up to the end of the study
agree to abstain from coffein consumption throughout study

You may not qualify if…

positive urine or blood test for drugs of abuse not under a physician's prescription
positive for HIV or HCV, or HBV with clinical symptoms or history of hepatitis
uncontrolled hypertension
renal transplant, dialysis patient, nephritic syndrome
clinically significant cardiovascular, central nervous system, gastrointestinal or liver disease or disorder

Where it is running

Study site — Orlando, Florida, United States
Study site — Knoxville, Tennessee, United States
Study site — Christchurch, New Zealand

Full record on ClinicalTrials.gov

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