NCT01426906

Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	Ketoconazole	Period 1 : LC15-0444 Period 2 : LC15-0444 with ketoconazole
DRUG	rifampicin	Period 1 : LC15-0444 Period 2 : LC15-0444 with rifampicin

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-09-01
• Last updated: 2011-09-01

Locations

1 site across 1 country: South Korea