Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Open-Label, Drug-Drug Interaction Study To Evaluate The Effect Of Ketoconazole Or Rifampicin On The Pharmacokinetic Characteristics And Safety Of Lc15-0444 In Healthy Male Volunteers

Conditions
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Healthy Male Volunteers

Intervention / Treatment
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* Drug: Ketoconazole
* Drug: rifampicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study A<br> | Drug: Ketoconazole<br>* Period 1 : LC15-0444 Period 2 : LC15-0444 with ketoconazole<br>|
| Experimental: Study B<br> | Drug: rifampicin<br>* Period 1 : LC15-0444 Period 2 : LC15-0444 with rifampicin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | Until Day 18 or 20 | 
| AUC(last) |  | Until Day 18 or 20 | 
| AUC(0-24hr) |  | Until Day 18 or 20 | 
| Tmax |  | Until Day 18 or 20 | 
| t(1/2beta) |  | Until Day 18 or 20 | 
| (6-b-hydrocortisol)/(cortisol) ratio |  | Until Day 20 |