Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

NCT ID: NCT01426906

Last Updated: 2011-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-03-31

Brief Summary

A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male Volunteers.

Detailed Description

This study is a randomized, open-label, 2-period, 3-treatment, 1-sequence, drug-drug interaction study in healthy volunteers to evaluate effect of ketoconazole or rifampicin on the PK characteristic and safety of LC15-0444.

Eligibility for participation of this study will be determined by demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks(-28 d ~ -2 d) before the first drug administration(1 d). Eligible subjects will be randomized to one of study treatment groups.

According to the characteristics of anti-diabetic drugs, it is expected to be administered with other drugs in many patients. Therefore, Drug-Drug Interaction with CYP3A4 inducer and inhibitor should be identified in this trial.

Conditions

Healthy Male Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study A

Group Type: EXPERIMENTAL

Ketoconazole

Intervention Type: DRUG

Period 1 : LC15-0444 Period 2 : LC15-0444 with ketoconazole

Study B

Group Type: EXPERIMENTAL

rifampicin

Intervention Type: DRUG

Period 1 : LC15-0444 Period 2 : LC15-0444 with rifampicin

Interventions

Ketoconazole

Period 1 : LC15-0444 Period 2 : LC15-0444 with ketoconazole

Intervention Type: DRUG

rifampicin

Period 1 : LC15-0444 Period 2 : LC15-0444 with rifampicin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Is a healthy male between 20 and 50 years old
• Has BMI result between 19 and 26 kg/m2 at screening; and a total body weight over 55 kg. BMI(kg/m2) = body weight(kg)/{height(m)}2.
• Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
• Agrees to use an adequate means of contraception during clinical trials

Exclusion Criteria

• Subjects with evidence or history of clinically significant hepatic, renal, digestive, neurologic, pulmonary, musculoskeletal, endocrine, hematological, cardiovascular or psychiatric disease
• Subjects with evidence or history of gastrointestinal disease or surgery possibly affecting drug absorption.
• Subjects with history of hypersensitivities or clinically significant adverse events caused by DPPIV inhibitors, ketoconazole, rifampicin, and other drugs
• Subjects who have donated a unit of blood within 60 days or blood components within 30 days before the first administration of the investigational product.
• Subjects who consume excessive alcohol or caffeine; who excessively smoke

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

Noh YH, Lim HS, Jin SJ, Kim MJ, Kim YH, Sung HR, Choi HY, Bae KS. Effects of ketoconazole and rifampicin on the pharmacokinetics of gemigliptin, a dipeptidyl peptidase-IV inhibitor: a crossover drug-drug interaction study in healthy male Korean volunteers. Clin Ther. 2012 May;34(5):1182-94. doi: 10.1016/j.clinthera.2012.04.001. Epub 2012 Apr 24.

Reference Type: DERIVED

PMID: 22534255 (View on PubMed)

Other Identifiers

LG-DPCL007

Identifier Type: -

Identifier Source: org_study_id