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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO5024048

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
• United States
  • Florida
    • Orlando, Florida, United States, 32809
  • Tennessee
    • Knoxville, Tennessee, United States, 37920

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Normal Renal Function	Drug: RO5024048; multiple oral doses for 5 days
Experimental: 2; Mild Renal Impairment	Drug: RO5024048; multiple oral doses for 5 days
Experimental: 3; Moderate Renal Impairment	Drug: RO5024048; multiple oral doses for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 6, 2010
• First Posted (Estimate): April 8, 2010

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PP21536