Healthy Male Volunteers
Conditions
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.
Interventions
DRUGKetoconazole
Period 1 : LC15-0444 Period 2 : LC15-0444 with ketoconazole
DRUGrifampicin
Period 1 : LC15-0444 Period 2 : LC15-0444 with rifampicin
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed