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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099904
• Other study ID #: PP21536
• Status: Completed
• Phase: Phase 1
• First received: April 6, 2010
• Last updated: November 1, 2016
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO5024048
multiple oral doses for 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No