Clinical trial NCT01426906: Pharmacokinetic Drug Interaction Study in Healthy Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Cmax
timeFrame: Until Day 18 or 20
measure: AUC(last)
timeFrame: Until Day 18 or 20
measure: AUC(0-24hr)
timeFrame: Until Day 18 or 20
measure: Tmax
timeFrame: Until Day 18 or 20
measure: t(1/2beta)
timeFrame: Until Day 18 or 20
measure: (6-b-hydrocortisol)/(cortisol) ratio
timeFrame: Until Day 20
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Noh YH, Lim HS, Jin SJ, Kim MJ, Kim YH, Sung HR, Choi HY, Bae KS. Effects of ketoconazole and rifampicin on the pharmacokinetics of gemigliptin, a dipeptidyl peptidase-IV inhibitor: a crossover drug-drug interaction study in healthy male Korean volunteers. Clin Ther. 2012 May;34(5):1182-94. doi: 10.1016/j.clinthera.2012.04.001. Epub 2012 Apr 24.