Prucalopride Subjects With Renal Impairment

NCT01674192 | Completed Phase 1

• 1 other identifier: PRU-USA-6
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• To characterize the Pharmacokinetic profile of prucalopride in subjects with various degrees of renal impairement

Secondary Outcomes (1)

• Secondary efficacy variables: to evaluate the safety and tolerability of prucalopride in subjects with various degrees of renal impairement

Study Arms (1)

prucalopride

EXPERIMENTAL

single dose of 2 mg prucalopride

Drug: prucalopride

Interventions

prucalopride DRUG

single dose of 2 mg prucalopride

prucalopride

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and 75 years, inclusive;
• Males or females. Females were to be of non-childbearing potential.
• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Movetis: lead

Related Publications (1)

• Smith WB, Mannaert E, Verhaeghe T, Kerstens R, Vandeplassche L, Van de Velde V. Effect of renal impairment on the pharmacokinetics of prucalopride: a single- dose open-label Phase I study. Drug Des Devel Ther. 2012;6:407-15. doi: 10.2147/DDDT.S36142. Epub 2012 Dec 18.

  PMID: 23269861 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• W. Smith, M.D.

  New Orleans Center for Clinical Research, 2820 Canal Street, New Orleans, LA 70119

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 28, 2012
• Study Start: July 1, 1997
• Primary Completion: August 1, 1999
• Study Completion: August 1, 1999
• Last Updated: August 28, 2012

Record last verified: 2012-06