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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO5024048

• Registration Number: NCT01099904
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-06
• Study First Posted: 2010-04-08
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	RO5024048	Mild Renal Impairment
1	RO5024048	Normal Renal Function
3	RO5024048	Moderate Renal Impairment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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