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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01099904
• Collaborator: (none)
• Enrollment: 30
• Locations: 3
• Arms: 3
• Duration (Months): 6
• Patients Per Site: 10
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: RO5024048	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: The Effect of Renal Function on the Pharmacokinetics of RO4995855 (Parent of ProDrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Orlando	Florida	United States	32809
2		Knoxville	Tennessee	United States	37920
3		Christchurch		New Zealand	8011

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01099904
• Other Study ID Numbers: PP21536
• First Posted: Apr 8, 2010
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

Study Results

No Results Posted as of Nov 2, 2016