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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RO5024048

Study type: Interventional

Funder types: Industry

Identifiers

NCT01099904

PP21536

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

30 participants in 3 patient groups

1

Experimental group

Description:

Normal Renal Function

Treatment:

Drug: RO5024048

2

Experimental group

Description:

Mild Renal Impairment

Treatment:

Drug: RO5024048

3

Experimental group

Description:

Moderate Renal Impairment

Treatment:

Drug: RO5024048