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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 6, 2010
Last updated: November 1, 2016
Last verified: November 2016
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 Intervention Phase
Healthy Volunteer
Drug: RO5024048
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl [ Time Frame: sampling days 1 and 3-11 ]

Secondary Outcome Measures:
  • Effect of renal impairment on safety and tolerability: Adverse events, vital signs, ECG, laboratory parameters [ Time Frame: Throughout study, ECG and laboratory assessments days 3, 5, 6 and 17 ]

Enrollment: 30
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01099904

United States, Florida
Orlando, Florida, United States, 32809
United States, Tennessee
Knoxville, Tennessee, United States, 37920
New Zealand
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01099904     History of Changes
Other Study ID Numbers: PP21536
Study First Received: April 6, 2010
Last Updated: November 1, 2016 processed this record on May 25, 2017