NCT01391663

Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Dose Study of the Pharmacokinetics and Pharmacodynamics of Alogliptin 12.5 mg, 25 mg and 50 mg in Healthy Korean Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the Pharmacokinetics and Pharmacodynamics of alogliptin after a single or multiple administrations, once daily (QD), of oral alogliptin in healthy Korean subjects.

Detailed description

Alogliptin is a selective, orally available inhibitor of dipeptidyl peptidase-4 being developed by Takeda Global Research \& Development Center, Inc. as a treatment for type 2 diabetes mellitus. Inhibition of dipeptidyl peptidase-4 (DPP-4) prolongs the action of 2 important incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). These hormones are responsible for increasing insulin synthesis, regulating β-cell proliferation, inhibiting gastric emptying and inhibiting glucagon secretion. Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. As development of alogliptin expands to other countries, additional studies are needed to bridge between the data previously acquired. The main objective of this study is to assess the pharmacokinetics and pharmacodynamics of alogliptin in healthy Korean participants.

Conditions

• Pharmacokinetics and Pharmacodynamics

Interventions

Type	Name	Description
DRUG	Alogliptin	Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
DRUG	Alogliptin	Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
DRUG	Alogliptin	Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-07-12
• Last updated: 2013-03-22
• Results posted: 2013-03-22

Locations

1 site across 1 country: South Korea