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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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01099904
First received: April 6, 2010
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This open-label, parallel group study will evaluate the effect of renal function on the pharmacokinetics of RO4995855 following multiple oral dose administratio n of RO5024048 and assess the effect of renal impairment on safety and tolerabil ity of RO5024048. Adult males or females with either normal renal function or mi ld 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
Endpoint Classification: Pharmacokinetics Study
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

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099904

Locations
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01099904     History of Changes
Other Study ID Numbers: PP21536
Study First Received: April 6, 2010
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014