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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01099904




Registration number
NCT01099904
Ethics application status
Date submitted
6/04/2010
Date registered
6/04/2010
Date last updated
1/11/2016

Titles & IDs
Public title
A Study on the Effect of Renal Function on the Pharmacakokinetics of RO5024048 (Parent of Prodrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
Scientific title
The Effect of Renal Function on the Pharmacokinetics of RO4995855 (Parent of ProDrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
Secondary ID [1] 0 0
PP21536
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO5024048

Experimental: 1 - Normal Renal Function

Experimental: 2 - Mild Renal Impairment

Experimental: 3 - Moderate Renal Impairment


Treatment: Drugs: RO5024048
multiple oral doses for 5 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl
Timepoint [1] 0 0
sampling days 1 and 3-11
Secondary outcome [1] 0 0
Effect of renal impairment on safety and tolerability: Adverse events, vital signs, ECG, laboratory parameters
Timepoint [1] 0 0
Throughout study, ECG and laboratory assessments days 3, 5, 6 and 17

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01099904
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications