Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers

NCT ID: NCT01807000

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-18
• Study Completion Date: 2013-04-28

Brief Summary

Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C] Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly Prucalopride Succinate or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Radiolabeled Prucalopride Succinate

Group Type: EXPERIMENTAL

Radiolabeled Prucalopride Succinate

Intervention Type: DRUG

A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.

Interventions

Radiolabeled Prucalopride Succinate

A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males aged between 18 and 50 years, inclusive
• Body mass index (BMI) of ≥18 and ≤30 kg/m2
• No more than 2 bowel movements per day or fewer than 3 bowel movement per week
• Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion Criteria

• Have participated in a [14C]-study within the last 6 months.
• Exposure to clinically significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring).
• Male subjects who consume more than 21 units of alcohol per week or 3 units per day.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Covance Global Clinical Research Unit Inc.

Madison, Wisconsin, United States

Countries

United States

References

Flach S, Scarfe G, Dragone J, Ding J, Seymour M, Pennick M, Pankratz T, Troy S, Getsy J. A Phase I Study to Investigate the Absorption, Pharmacokinetics, and Excretion of [(14)C]Prucalopride After a Single Oral Dose in Healthy Volunteers. Clin Ther. 2016 Sep;38(9):2106-15. doi: 10.1016/j.clinthera.2016.08.003. Epub 2016 Sep 7.

Reference Type: DERIVED

PMID: 27614912 (View on PubMed)

Other Identifiers

SPD555-104

Identifier Type: -

Identifier Source: org_study_id