Pharmacokinetic Drug Interaction Study in Healthy Male Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study A
|
Drug: Ketoconazole
Period 1 : LC15-0444 Period 2 : LC15-0444 with ketoconazole
|
| Experimental: Study B
|
Drug: rifampicin
Period 1 : LC15-0444 Period 2 : LC15-0444 with rifampicin
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asan Medical Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- LG Life Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LG-DPCL007