The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea

NCT01133431 | Completed Phase 1

• 1 other identifier: CKD-19HPS10A
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.

Conditions

Healthy Male Volunteer

Keywords

CKD-501; Glimepiride; Placebo; Healthy male volunteer; Pharmacokinetic; Metabolite

Outcome Measures

Primary Outcomes (1)

• To evaluate the Pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects

  Blood sampling timepoint : Day 1(0hr), Day 4(0hr), Day 5(0hr),0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 12hr, 24hr(Day 6)- total 16 timepoints per period

  0-24 hrs

Secondary Outcomes (1)

• To confirm and evaluate the pharmacokinetic characters of main metabolites of CKD-501

  0-24 hrs

Study Arms (2)

CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride

EXPERIMENTAL

This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.

Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet; Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet

CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride

EXPERIMENTAL

This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.

Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet; Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet

Interventions

CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet DRUG

From day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1.

Also known as: CKD-501 : Lobeglitazone

CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride; CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride

CKD-501 placebo tablet, Glimepiride 4 mg tablet DRUG

From day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2.

Also known as: CKD-501 : Lobeglitazone

CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride; CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male adults aged between 20 and 45 during screening period
• Weight more than 45kg and within ±20% range of Ideal Boby Weight
• Agreement with written informed consent

You may not qualify if:

• Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
• Subject has a history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
• Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
• Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
• Inadequate laboratory test result
• AST(SGOT) or ALT(SGPT) \> 1.25 x upper limit of normal range
• Total bilirubin \> 1.5 x upper limit of normal range
• Clinically significant allergic disease(except for mild allergic rhinitis is not needed medication)
• Subject with known for hypersensitivity reactions to glitazones or sulfonylureas
• Previously participated in other trial within 60 days
• Medication with drug-mediated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
• Subject has taken abnormal meals which affects the ADME of drug
• Impossible to taking the institutional standard meal
• Previously donate whole blood within 60 days or component blood within 20 days
• Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

The Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

lobeglitazone; Tablets; glimepiride

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ji Young Park, Ph.D.

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 28, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 10, 2010

Record last verified: 2010-05

Locations

KR (1)