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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Period 1 : LC15-0444 Period 2 : LC15-0444 with ketoconazole
Period 1 : LC15-0444 Period 2 : LC15-0444 with rifampicin
Asan Medical Center
Seoul, South Korea
Cmax
Time frame: Until Day 18 or 20
AUC(last)
Time frame: Until Day 18 or 20
AUC(0-24hr)
Time frame: Until Day 18 or 20
Tmax
Time frame: Until Day 18 or 20
t(1/2beta)
Time frame: Until Day 18 or 20
(6-b-hydrocortisol)/(cortisol) ratio
Time frame: Until Day 20
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.