Drug-drug Interaction Study (CKD-501, Ketoconazole)

This study has been completed.
Sponsor:
Collaborator:
Severance Hospital
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01330563
First received: April 5, 2011
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic characteristics of CKD-501 in healthy subject.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: CKD-501, Ketoconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Drug-Drug Interaction Study to Investigate the Effect of Ketoconazole on the Pharmacokinetic Properties of CKD-501 in Healthy Male Volunteer: Open, Randomised, 2-way Crossover, Clinical Trial

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • CKD-501 AUC [ Time Frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CKD-501 Cmax [ Time Frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr ] [ Designated as safety issue: No ]
  • CKD-501 Tmax [ Time Frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CKD-501

Subjects received Ketoconazole 200 mg twice daily for 5 days in one period and in the other period, Subjects don't receive Ketoconazole.

In addition, The CKD-501 is administered on day 5

Drug: CKD-501, Ketoconazole
Subjects received single 0.5mg doses of CKD-501 alone in one period and, in the other period, Ketoconazole 200 mg twice daily for 5 day with the CKD-501 dose also co-administered with Ketoconazole on day 5.
Other Name: Lobeglitazone, Ketoconazole
Experimental: ketoconazole

Subjects received Ketoconazole 200 mg twice daily for 5 days in one period and in the other period, Subjects don't receive Ketoconazole.

In addition, The CKD-501 is administered on day 5

Drug: CKD-501, Ketoconazole
Subjects received single 0.5mg doses of CKD-501 alone in one period and, in the other period, Ketoconazole 200 mg twice daily for 5 day with the CKD-501 dose also co-administered with Ketoconazole on day 5.
Other Name: Lobeglitazone, Ketoconazole

Detailed Description:

From day 1 to day 5, Ketoconazole 200mg is administered twice daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg is co-administered Group 1 patients at period 1. After 28 day-break, period 2 will CKD-501 0.5mg administered on day 5. Period 2 will not Ketoconazole administered.

Group 2 is administered in reverse order.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 20 aged and 45 years old in healthy males
  • 18.5 ≤ IBW < 25
  • Agreement with written informed consent

Exclusion Criteria:

  • Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
  • Medication with drug-mediated induction/inhibition metabolic enzyme such as Midazolam within 1 month or with may affect the clinical trial
  • Subject has taken abnormal meals which affects the ADME of drug
  • Subject has a history(such as gastric or duodenal ulcer, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
  • Substance abuse, or a history of drug abuse showed a positive for the party
  • Continued to be taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
  • Previously participated in other trial within 60 days
  • Previously donate whole blood within 60 days or component blood within 30 days
  • Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
  • SBP >140 mmHg, SBP < 90 mmHg or DBP > 90 mmHg, DBP < 50 mmHg or Pulse > 100 per/min, Pulse < 50 per/min
  • 12-lead ECG, QTc > 450 msec
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330563

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Severance Hospital
Investigators
Principal Investigator: Minsoo Park Severance Hospital
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical, Chin Kim
ClinicalTrials.gov Identifier: NCT01330563     History of Changes
Other Study ID Numbers: 19HPS11G
Study First Received: April 5, 2011
Last Updated: June 28, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Drug-Drug interaction between the CKD-501 and ketoconazole

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014