Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426906
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : September 1, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: Ketoconazole Drug: rifampicin 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Cmax [ Time Frame: Until Day 18 or 20 ]
  2. AUC(last) [ Time Frame: Until Day 18 or 20 ]
  3. AUC(0-24hr) [ Time Frame: Until Day 18 or 20 ]
  4. Tmax [ Time Frame: Until Day 18 or 20 ]
  5. t(1/2beta) [ Time Frame: Until Day 18 or 20 ]
  6. (6-b-hydrocortisol)/(cortisol) ratio [ Time Frame: Until Day 20 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01426906

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: LG Life Sciences Identifier: NCT01426906     History of Changes
Other Study ID Numbers: LG-DPCL007
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: September 1, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers