Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

LG Life Sciences

Status and phase

Completed

Phase 1

Conditions

Healthy Male Volunteers

Treatments

Drug: Ketoconazole

Drug: rifampicin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01426906

LG-DPCL007

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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