A Study on the Effect of Renal Function on the Pharmacakokinetics of RO5024048 (Parent of Prodrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/3/2016 |
| Start Date: | March 2010 |
| End Date: | September 2010 |
The Effect of Renal Function on the Pharmacokinetics of RO4995855 (Parent of ProDrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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