Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment (HI)

Movetis

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: prucalopride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01134185

M0001-C103

Details and patient eligibility

About

This is a single centre, open-label phase I trial to investigate the effects of moderate to severe hepatic impairment on the pharmacokinetics of prucalopride in comparison with healthy volunteers. Furthermore the short-term safety and tolerability of a single dose of prucalopride will be assessed.

Full description

In this phase I trial two groups of 6 to 8 hepatically impaired subjects will be evaluated. The first group are the moderate hepatic impairment (Grade B) subjects and the second group the severe hepatic impairment (grade C) subjects. Subjects for both groups will be recruited and treated in parallel. After all subjects with hepatic impairment completed the treatment a third group with matching healthy volunteers will be recruited. Eight healthy subjects will be selected matching for age, gender and weight (BMI based).

The subjects will receive a single dose of 2 mg prucalopride in the morning after overnight fasting followed by the consumption of a standard breakfast after 2 hours.

Pharmacokinetic evaluation of blood samples will be done immediately before and at a specific timepoint up to 120h post-dosing. Urine samples will be taken to determine prucalopride.

Adverse events, including serious adverse events, will be reported from signing the Informed Consent until the last visit. Safety blood samples and a urine sample for urinalysis will be taken.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Main inclusion criteria for hepatic impairment subjects:

  • Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to Child-Pugh classification; Hepatic impairment must be stable, both clinically and biochemically;
  • Within the normal range of body height and weight on the basis of the Body Mass Index.

• Main inclusion criteria for healthy subjects:

  • Matching on sex, age and weight(BMI based).

Exclusion criteria

• History or suspicion of barbiturate, amphetamine or narcotic abuse; Suspicion of current alcohol abuse;
• Clinical suspicion or laboratory evidence of unstable hepatic impairment or acute liver injury;
• Clinically relevant renal disease as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Group I

Active Comparator group

Description:

Moderate hepatic impairment (grade B)

Treatment:

Drug: prucalopride

Drug: prucalopride

Drug: prucalopride

Group II

Active Comparator group

Description:

Severe hepatic impairment (grade C)

Treatment:

Drug: prucalopride

Drug: prucalopride

Drug: prucalopride

Group III

Active Comparator group

Description:

healthy subjects

Treatment:

Drug: prucalopride

Drug: prucalopride

Drug: prucalopride