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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

April 6, 2010
November 3, 2014
March 2010
September 2010   (final data collection date for primary outcome measure)
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 ]
Pharmacokinetics multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl [ Time Frame: sampling days 1 and 3-11 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01099904 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study on the Effect of Renal Function on the Pharmacakokinetics of RO5024048 (Parent of Prodrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
The Effect of Renal Function on the Pharmacokinetics of RO4995855 (Parent of ProDrug RO5024048) Following Multiple Oral Dose Administration of RO5024048

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Healthy Volunteer
Drug: RO5024048
multiple oral doses for 5 days
  • Experimental: 1
    Normal Renal Function
    Intervention: Drug: RO5024048
  • Experimental: 2
    Mild Renal Impairment
    Intervention: Drug: RO5024048
  • Experimental: 3
    Moderate Renal Impairment
    Intervention: Drug: RO5024048
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   New Zealand
 
NCT01099904
PP21536
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP