- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01674192
Prucalopride Subjects With Renal Impairment
Single Dose Pharmacokinetic Trial of Oral Prucalopride (R093877) in Subjects With Mild, Moderate and Severe Renal Impairment
The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of prucalopride in subjects with various degrees of renal impairment compared with normal renal function and to monitor the safety profile of prucalopride in subjects with renal impairment.
Hypothesis:
Prucalopride might accumulate and exhibit a different pharmacokinetic profile in renally impaired subjects compared with the normal population.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
All subjects had to meet the following inclusion criteria:
- Between the ages of 18 and 75 years, inclusive;
- Males or females. Females were to be of non-childbearing potential.
Normal subjects had to meet the following additional inclusion criteria:
- Demographically comparable to the subjects with renal impairment, within 30% of mean weight and height and 10% of the mean age;
- Physical examination, clinical laboratory results, and 12-lead ECG within normal limits at screening;
- No intake of medication, including over-the-counter medication, during a pre-trial 7-day drug-free washout period;
Subjects with renal impairment had to meet the following additional inclusion criteria:
- Stable severity of renal disease;
- Concomitant medications to treat underlying disease states or medical conditions related to renal insufficiency were allowed;
- Stable dose of medication and/or treatment regimen from 2 months prior to and during the trial;
- Subjects with stable cardiovascular disease could be enrolled, provided that the investigator felt their condition would not interfere with the results of the trial.
Exclusion Criteria:
All subjects who met any of the following criteria were excluded from the trial:
- History of hypersensitivity to prucalopride or inactive ingredients in the prucalopride capsule or to related prokinetic compounds;
- Use of any other investigational drug within 30 days prior to signing the consent or intention to take any investigational drug during the trial;
- History of significant blood loss, or blood plasma donation (500mL) within the last 30 days;
- Pregnancy or breast feeding;
- Gastrointestinal (GI) surgery within 3 months, or history of major GI surgery with potential compromise of drug absorption or metabolism;
Normal subjects who met any of the following criteria were excluded from the trial:
- Any abnormal medical history, physical examination, ECG, or laboratory results;
- Use of medications 7 days prior to and during the trial.
- Subjects with renal impairment who met any of the following criteria were excluded from the trial.
- Any abnormality in medical history, physical examination, ECG, or laboratory results that, in the opinion of the investigator, might affect the safety of the subject;
- History of uric acid stone disease, uricosuria, or gout, or current hyperuricemia;
- Renal transplants, lupus erythematosus, or renal carcinoma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: prucalopride
single dose of 2 mg prucalopride
|
single dose of 2 mg prucalopride
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To characterize the Pharmacokinetic profile of prucalopride in subjects with various degrees of renal impairement
|
Secondary Outcome Measures
Outcome Measure |
---|
Secondary efficacy variables: to evaluate the safety and tolerability of prucalopride in subjects with various degrees of renal impairement
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: W. Smith, M.D., New Orleans Center for Clinical Research, 2820 Canal Street, New Orleans, LA 70119
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRU-USA-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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