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Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01426906
First received: August 31, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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 Intervention Phase
Healthy Male Volunteers
 Drug: Ketoconazole
Drug: rifampicin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Cmax [ Time Frame: Until Day 18 or 20 ] [ Designated as safety issue: No ]
  • AUC(last) [ Time Frame: Until Day 18 or 20 ] [ Designated as safety issue: No ]
  • AUC(0-24hr) [ Time Frame: Until Day 18 or 20 ] [ Designated as safety issue: No ]
  • Tmax [ Time Frame: Until Day 18 or 20 ] [ Designated as safety issue: No ]
  • t(1/2beta) [ Time Frame: Until Day 18 or 20 ] [ Designated as safety issue: No ]
  • (6-b-hydrocortisol)/(cortisol) ratio [ Time Frame: Until Day 20 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426906

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

No publications provided by LG Life Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01426906     History of Changes
Other Study ID Numbers: LG-DPCL007
Study First Received: August 31, 2011
Last Updated: August 31, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Ketoconazole
Rifampin
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
 Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013