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

NCT01099904 | Completed Phase 1

• 1 other identifier: PP21536
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 3

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (3)

1

EXPERIMENTAL

Normal Renal Function

Drug: RO5024048

2

EXPERIMENTAL

Mild Renal Impairment

Drug: RO5024048

3

EXPERIMENTAL

Moderate Renal Impairment

Drug: RO5024048

Interventions

RO5024048 DRUG

multiple oral doses for 5 days

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Orlando, Florida, 32809, United States

Location

Unknown Facility

Knoxville, Tennessee, 37920, United States

Location

Unknown Facility

Christchurch, 8011, New Zealand

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 8, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NZ (1); US (2)