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Trial registered on ANZCTR


Registration number
ACTRN12611001254987
Ethics application status
Approved
Date submitted
5/12/2011
Date registered
7/12/2011
Date last updated
7/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of pitavastatin in different SLCO1B1 backgrounds on repaglinide pharmacokinetics and pharmacodynamics in healthy Chinese males
Scientific title
Effects of SLCO1B1 Polymorphism and Pitavastatin on the Pharmacokinetics of Repaglinide in Chinese Healthy Volunteers
Secondary ID [1] 273538 0
ChiCTR-TRC-11001742
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chinese Healthy Volunteers 279340 0
Condition category
Condition code
Other 279524 279524 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 283851 0
Treatment: Drugs
Comparator / control treatment
randomized, placebo-controlled, crossover study
The participants were randomly divided into two treatment groups using statistical software.
In each phase, the participants were administrated either 4 mg pitavastatin or placebo once daily for 5 days.
After a washout period of at least two weeks,two arms changed the treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 286093 0
Effects of pitavastatin pretreatment on repaglinide pharmacokinetics
Timepoint [1] 286093 0
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.
Primary outcome [2] 286094 0
Effect of pitavastatin pretreatment on repaglinide pharmacokinetics and association with SLCO1B1 genetic polymorphisms
Timepoint [2] 286094 0
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 [1] 295163 0
SLOC1B1 SNPs, haplotypes, and genotypes in healthy Chinese males
First counting the genotypic frequencies, then based on these SNPs, SLOC1B1 haplotypes (*1a, *1b, and *15) were inferred by PHASE 2.0.
Timepoint [1] 295163 0
before repaglinide administration

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1 numbered containers.
2 randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using randomisation table created by computer soft ware.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3995 0
China
State/province [1] 3995 0

Funding & Sponsors
Funding source category [1] 284325 0
Self funded/Unfunded
Name [1] 284325 0
Third Xiangya Hospital, Central South University
Address [1] 284325 0
Third Xiangya Hospital, Central South University, Changsha, Hunan 410013 China
Country [1] 284325 0
China
Primary sponsor type
Hospital
Name
Third Xiangya Hospital, Central South University
Address
Third Xiangya Hospital, Central South University, Changsha, Hunan 410013 China
Country
China
Secondary sponsor category [1] 283269 0
Individual
Name [1] 283269 0
Guo-Ping Yang
Address [1] 283269 0
Third Xiangya Hospital, Central South University, Changsha, Hunan 410013 China
Country [1] 283269 0
China
Other collaborator category [1] 260370 0
Individual
Name [1] 260370 0
Min Song
Address [1] 260370 0
Zhongshan Hospital, Xiamen University, Xiamen, 361004 China
Country [1] 260370 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286287 0
The Coordinating Ethics Committee of the Xiang Ya Third Hospital of Central South University
Ethics committee address [1] 286287 0
Third Xiangya Hospital, Central South University, Changsha, Hunan 410013 China
Ethics committee country [1] 286287 0
China
Date submitted for ethics approval [1] 286287 0
06/02/2009
Approval date [1] 286287 0
12/02/2009
Ethics approval number [1] 286287 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33499 0
Address 33499 0
Country 33499 0
Phone 33499 0
Fax 33499 0
Email 33499 0
Contact person for public queries
Name 16746 0
Guo-Ping Yang
Address 16746 0
Third Xiangya Hospital, Central South University, Changsha, Hunan 410013 China
Country 16746 0
China
Phone 16746 0
+86,731,8861,8326
Fax 16746 0
+86,731,8861,8326
Email 16746 0
ygp9880@163.com
Contact person for scientific queries
Name 7674 0
Guo-Ping Yang
Address 7674 0
Third Xiangya Hospital, Central South University, Changsha, Hunan 410013 China
Country 7674 0
China
Phone 7674 0
+86,731,8861,8326
Fax 7674 0
+86,731,8861,8326
Email 7674 0
ygp9880@163.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary