NCT01330563

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

3 months

First QC Date

April 5, 2011

Last Update Submit

June 28, 2011

Conditions

Type 2 Diabetes Mellitus

Keywords

Drug-Drug interaction between the CKD-501 and ketoconazole

Outcome Measures

Primary Outcomes (1)

  • CKD-501 AUC

    0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr

Secondary Outcomes (2)

  • CKD-501 Cmax

    0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr

  • CKD-501 Tmax

    0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr

Study Arms (2)

CKD-501

EXPERIMENTAL

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

ketoconazole

EXPERIMENTAL

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

Interventions

CKD-501, KetoconazoleDRUG

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.

Also known as: Lobeglitazone, Ketoconazole
CKD-501ketoconazole

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • lead ECG, QTc \> 450 msec
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 25047497DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazoneKetoconazole

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Minsoo Park

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 7, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations

KR(1)