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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-501, Ketoconazole
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Drug-Drug interaction between the CKD-501 and ketoconazole

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CKD-501

ketoconazole

Arm Description

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

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

Outcomes

Primary Outcome Measures

CKD-501 AUC

Secondary Outcome Measures

CKD-501 Cmax
CKD-501 Tmax

Full Information

First Posted
April 5, 2011
Last Updated
June 28, 2011
Sponsor
Chong Kun Dang Pharmaceutical
Collaborators
Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01330563
Brief Title
Drug-drug Interaction Study (CKD-501, Ketoconazole)
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chong Kun Dang Pharmaceutical
Collaborators
Severance Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Drug-Drug interaction between the CKD-501 and ketoconazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CKD-501
Arm Type
Experimental
Arm Description
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
Arm Title
ketoconazole
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CKD-501, Ketoconazole
Other Intervention Name(s)
Lobeglitazone, Ketoconazole
Intervention Description
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.
Primary Outcome Measure Information:
Title
CKD-501 AUC
Time Frame
0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr
Secondary Outcome Measure Information:
Title
CKD-501 Cmax
Time Frame
0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr
Title
CKD-501 Tmax
Time Frame
0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minsoo Park
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25047497
Citation
Sil Oh E, Ok Kim C, Kim KH, Kim YN, Kim C, Lee JI, Park MS. Effect of ketoconazole on lobeglitazone pharmacokinetics in Korean volunteers. Clin Ther. 2014 Jul 1;36(7):1064-71. doi: 10.1016/j.clinthera.2014.05.064. Erratum In: Clin Ther. 2014 Oct 1;36(10):1480.
Results Reference
derived

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

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