Clinical trial NCT01330563: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug-Drug interaction between the CKD-501 and ketoconazole
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Severance Hospital
First posted: 2011-04-07
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: CKD-501 AUC
timeFrame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr
Secondary outcomes:
measure: CKD-501 Cmax
timeFrame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr
measure: CKD-501 Tmax
timeFrame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Minsoo Park
role: PRINCIPAL_INVESTIGATOR
References:
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.