Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: Ketoconazole; Drug: rifampicin

• Registration Number: NCT01426906
• Lead Sponsor: LG Life Sciences

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-08
• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-08-31
• Last Update Submitted: 2011-08-31
• Study First Posted: 2011-09-01
• Last Update Posted: 2011-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study A	Ketoconazole	-
Study B	rifampicin	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of