Hepatic ImpairmentPhase 1HINCT01134185
Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment
A Phase 1 study testing prucalopride in people with Hepatic Impairment, run by Movetis at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- prucalopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteRussia
- Study dates
- May 2010to Feb 2011
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pharmacokinetics, Safety and Tolerability of a Single Dose of Prucalopride, in Subjects With Moderate and Severe Hepatic Impairment, in Comparison With Healthy Subjects
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.
Read the detailed 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.
- Conditions
- Hepatic Impairment
- Being tested
- prucalopride
- Keywords
- Two groups of 8 hepatically impaired subjects, one group of 8 matched healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prucaloprideDrug
single oral dose of 2 mg prucalopride
prucaloprideDrug
single oral dose of 2 mg prucalopride
prucaloprideDrug
single dose of 2 mg prucalopride
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Moderate hepatic impairment (grade B) Receives: Drug: prucalopride |
| Group II | Active comparator | Severe hepatic impairment (grade C) Receives: Drug: prucalopride |
| Group III | Active comparator | healthy subjects Receives: Drug: prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Evaluation of prucalopride in blood immediately before and at 17 timepoints post dosing and in urine at 8 collection time points.
Measured: 6 days
Secondary outcomes (1)
Safety and tolerability
Evaluation of safety parameters by measuring adverse events, safety, blood and urine samples, ECGs, vital signs and physical examinations.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Movetis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134185
- Sponsor's protocol ID
- M0001-C103
- Acronym
- HI
- Status last verified
- Oct 2011
- First submitted
- 21 May 2010
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No