Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

Healthy Male Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426906
• Other study ID #: LG-DPCL007
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2011
• Last updated: August 31, 2011
• Start date: January 2011
• Est. completion date: March 2011

Study information

• Verified date: August 2011
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• Ketoconazole
Period 1 : LC15-0444 Period 2 : LC15-0444 with ketoconazole
• rifampicin
Period 1 : LC15-0444 Period 2 : LC15-0444 with rifampicin

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		Until Day 18 or 20	No
Primary	AUC(last)		Until Day 18 or 20	No
Primary	AUC(0-24hr)		Until Day 18 or 20	No
Primary	Tmax		Until Day 18 or 20	No
Primary	t(1/2beta)		Until Day 18 or 20	No
Primary	(6-b-hydrocortisol)/(cortisol) ratio		Until Day 20	No