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

Phase 4

Completed

• Conditions: Chinese Healthy Volunteers; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12611001254987
• Lead Sponsor: Third Xiangya Hospital, Central South University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

1) Subjects must be able to read and understand the contents of informed consent,and signed informed consent;
2) Age 18-55 years old, male, no more than 10 years in age difference with the same batch (including the boundary values);
3) Body weight > 50kg, the subjects body mass index (BMI) between 19-25kg/m2 (BMI = weight (kg) / height 2 (m2)), including the boundary values, the same batch weight difference should not be great;
4)No history of alcohol abuse or drug abuse, non-smokers;
5) They are ascertained to be healthy by physical examination such as blood pressure, heart rate, ECG, respiratory status, liver and kidney function and so on;
6) Subjects can be able to make good communication with researchers and complete research in accordance with the provisions of study.

Exclusion Criteria

1)It is known that there are allergies for active pharmaceutical ingredients or excipients;
2) Specific allergic history (asthma, urticaria, eczema, dermatitis), arrhythmia, bradycardia, hypotension, coronary heart disease, bronchial and cardiovascular diseases, diabetes, hyperthyroidism, Parkinson's disease, epilepsy , tremor, paralysis and any other diseases or physiological conditions interfering test results;
3) Subjects are receiving or have been received gastrointestinal problems, seizures, gastrointestinal ulcers, urinary tract infarction, mechanical intestinal obstruction, ureteral spasm, biliary tract disease and other treatment of depressive disorders or liver disease;
4) It is known that the factors can affect the venous blood of severe bleeding;
5) Some gastrointestinal tract diseases can affect drug absorption or metabolism;
6) Subjects have the history of drug abuse or positive urine drug test results within the past five years;
7) The combined use of drugs that affect glucose metabolism, such as corticosteroids and so on;
8) It is known to have used drugs that damage an organ within three months;
9) It is known to have used other drugs that may affect the metabolism of hypoglycemic drugs within 14 days before the test (such as monoamine oxidase inhibitors, non-selective ß-blockers, ACEI, non-steroidal anti-inflammatory drugs, salicylates, octreotide , alcohol, anabolic growth hormone, oral contraceptives, thiazide drugs, corticosteroids, danazol, thyroid hormones, sympathomimetics, ketoconazole, itraconazole, erythromycin, fluconazole, and other azole anti-fungal, rifampicin, phenytoin, trimethoprim, cyclosporine, macrolide antibiotics erythromycin and clarithromycin, cimetidine, indomethacin,etc);
10) A serious loss of blood or donating blood or plasma (300mL) within 30 days before the test;
11)Primary disease in vital organs;
12)Regular smokers or drinkers, that drinking more than 28 units of alcohol per week (1 unit: 285ml beer or 1 glass of wine or 25ml spirits) or weekly smoking over two or more cigarette;
13) Often using sedatives, sleeping pills, tranquilizers or other addictive drugs;
14) The researchers believe that some subjects should not be included.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effects of pitavastatin pretreatment on repaglinide pharmacokinetics[Blood samples (~7 ml) were drawn before repaglinide administration and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, and 8.0 h after repaglinide ingestion.];Effect of pitavastatin pretreatment on repaglinide pharmacokinetics and association with SLCO1B1 genetic polymorphisms[Blood samples (~7 ml) were drawn before repaglinide administration and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, and 8.0 h after repaglinide ingestion.]

Secondary Outcome Measures

Name	Time	Method
SLOC1B1 SNPs, haplotypes, and genotypes in healthy Chinese males<br>First counting the genotypic frequencies, then based on these SNPs, SLOC1B1 haplotypes (*1a, *1b, and *15) were inferred by PHASE 2.0.[before repaglinide administration]