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

The Effect of Renal Function on the Pharmacokinetics of RO4995855 (Parent of ProDrug RO5024048) Following Multiple Oral Dose Administration of RO5024048

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01099904

Enrollment

Registered

2010-04-08

Start date

2010-03-31

Completion date

2010-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief summary

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.

Interventions

DRUGRO5024048

multiple oral doses for 5 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl	sampling days 1 and 3-11

Secondary

Measure	Time frame
Effect of renal impairment on safety and tolerability: Adverse events, vital signs, ECG, laboratory parameters	Throughout study, ECG and laboratory assessments days 3, 5, 6 and 17

Countries

New Zealand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026