CompletedPhase 4ACTRN12611001254987

Effect of pitavastatin in different SLCO1B1 backgrounds on repaglinide pharmacokinetics and pharmacodynamics in healthy Chinese males

Effects of SLCO1B1 Polymorphism and Pitavastatin on the Pharmacokinetics of Repaglinide in Chinese Healthy Volunteers

Sponsor

Third Xiangya Hospital, Central South University

Enrollment

12 participants

Start Date

Mar 5, 2009

Study Type

Interventional

Conditions

Chinese Healthy Volunteers

Summary

1. SLCO1B1 genetic polymorphism had no effect on the pharmacokinetic profile of repaglinide. After repaglinide administration, higher concentrations were seen in the SLCO1B1*15 carriers. Two common SLCO1B1 single nucleotide polymorphisms (SNPs) c.A388G and c.T521C form four functionally distinct SLCO1B1 haplotypes: *1a (c.388A/c.521T), *1b (c.388G/c.521T), *5 (c.388A/c.521C), and *15 (c.388G/c.521C). 2. Pitavastatin can increase plasma concentrations of repaglinide independent of SLCO1B1 genetic polymorphism, but has no effect on pharmacodynamics of repaglinide in healthy volunteers.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This study examines how the cholesterol-lowering drug pitavastatin affects the way the body processes repaglinide (a diabetes medication) in people with different genetic backgrounds. Healthy Chinese men aged 18 to 55 with specific gene variants are enrolled to study drug interactions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Arm 1 4 mg pitavastatin once daily for 5 days, On day 5, 1 h after the last dose of pitavastatin administration, 4 mg of repaglinide was orally administrated. Arm 2 placebo, identical to pitavastati

Arm 1 4 mg pitavastatin once daily for 5 days, On day 5, 1 h after the last dose of pitavastatin administration, 4 mg of repaglinide was orally administrated. Arm 2 placebo, identical to pitavastatin only without the active ingredient once daily for 5 days,On day 5, 1 h after the last dose of placebo administration, 4 mg of repaglinide was orally administrated.

Locations(1)

China

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ACTRN12611001254987