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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

NCT ID: NCT01099904

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

Normal Renal Function

Group Type EXPERIMENTAL

RO5024048

Intervention Type DRUG

multiple oral doses for 5 days

2

Mild Renal Impairment

Group Type EXPERIMENTAL

RO5024048

Intervention Type DRUG

multiple oral doses for 5 days

3

Moderate Renal Impairment

Group Type EXPERIMENTAL

RO5024048

Intervention Type DRUG

multiple oral doses for 5 days

Interventions

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RO5024048

multiple oral doses for 5 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Orlando, Florida, United States

Site Status

Knoxville, Tennessee, United States

Site Status

Christchurch, , New Zealand

Site Status

Countries

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United States New Zealand

Other Identifiers

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PP21536

Identifier Type: -

Identifier Source: org_study_id