Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants
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|ClinicalTrials.gov Identifier: NCT01391663|
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : March 22, 2013
Last Update Posted : March 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pharmacokinetics and Pharmacodynamics||Drug: Alogliptin||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||July 2011|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
|Experimental: Alogliptin 12.5 mg QD||
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
Other Name: SYR-322
|Experimental: Alogliptin 25 mg QD||
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
Other Name: SYR-322
|Experimental: Alogliptin 50 mg QD||
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
Other Name: SYR-322
- Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter [ Time Frame: Day 1-4, Day 10 ]Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter [ Time Frame: Day 1-4, Day 10. ]Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug
- AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter [ Time Frame: Day 1-4 ]Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.
- AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter. [ Time Frame: Day 1-4, Day 10. ]Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.
- Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter [ Time Frame: Day 1-4 ]Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.
- Oral Clearance (CL/F) Pharmacokinetic Parameter [ Time Frame: Day 1-4 ]CL/F is apparent clearance of the drug from the plasma after administration of a single dose of the study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391663
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||Clinical Director Clinical Science||Takeda|