Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet (PGP inhibitor)

This study has been completed.
Sponsor:
Information provided by:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT00954304
First received: August 6, 2009
Last updated: September 10, 2010
Last verified: September 2010
  Purpose

The purposes of this study are to investigate the duration of P-glycoprotein inhibition after oral administration of HM30181AK tablet in healthy male subject and proper dose of HM30181AK tablet.


Condition Intervention Phase
Healthy
Drug: HM30181AK 1mg
Drug: HM30181AK 5mg
Drug: HM30181AK 15mg
Drug: HM30181AK 60mg
Drug: Loperamide 2mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial to Investigate the Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet in Healthy Male Subjects : An Open, Parallel Dose Group Design

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement. [ Time Frame: Day 1~Day 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the PK parameters (Cmax, AUClast, AUCinf, Tmax, T1/2, CL/F etc) of HM30181AK by measuring the blood concentration of HM30181AK [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1mg group
Administration of HM30181AK 1mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
Drug: HM30181AK 1mg
HM30181AK 1mg tablet
Drug: Loperamide 2mg
Loperamide 2mg capsule
Experimental: 5mg group
Administration of HM30181AK 5mg on day 4 and Loperamide 16mg(Loperamide 2mg x 8cap) on day 1,4,8,11,15
Drug: HM30181AK 5mg
HM30181AK 5mg tablet
Drug: Loperamide 2mg
Loperamide 2mg capsule
Experimental: 10mg group
Administration of HM30181AK 10mg(HM30181AK 5mg x 2tab)on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
Drug: HM30181AK 5mg
HM30181AK 5mg tablet
Drug: Loperamide 2mg
Loperamide 2mg capsule
Experimental: 15mg group
Administration of HM30181AK 15mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
Drug: HM30181AK 15mg
HM30181AK 15mg tablet
Drug: Loperamide 2mg
Loperamide 2mg capsule
Experimental: 60mg group
Administration of HM30181AK 60mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
Drug: HM30181AK 60mg
HM30181AK 60mg tablet
Drug: Loperamide 2mg
Loperamide 2mg capsule

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male volunteers aged 20 to 50 years at screening
  2. Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body weight

    • Ideal body weight = (height cm - 100) x 0.9
  3. Subjects who provided written, voluntary informed consent to participate in this clinical trial and to comply the directions including contraception after being fully informed of and understand this trial

Exclusion Criteria:

  1. Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system.
  2. History of the gastrointestinal diseases which may affect the absorption of oral drugs (e.g., Crohn's disease) or gastrointestinal operations (excluding simple typhlotomy and hernia repair).
  3. The following results in laboratory test

    • AST, ALT > 1.25 x upper limits of normal
  4. Systolic blood pressure below 100 mmHg or above 150 mmHg or diastolic blood pressure below 65 mmHg or above 95 mmHg in vital signs
  5. History of drug allergy or other allergies which are clinically significant
  6. History of drug abuse or positive reaction for drug abuse in urine screening test
  7. Subjects who took prescription drugs or herbal medicines within 2 weeks prior to the first day of drug administration or OTC or vitamin preparations within 1 week prior to the first day of drug administration If the subjects meet other criteria, they could participate in the trial in the judgement of investigator.)
  8. Subjects who have participated in other clinical trial within 2 months prior to the first day of drug administration
  9. Whole blood donation within 2 months prior to the first day of drug administration or apheresis donation within 2 weeks prior to the first day of drug administration
  10. Subject who are continuously drinking alcohol (over 21 units/week) or who cannot quit drinking during clinical trial period
  11. Subject who are smoking over 10 cigar/day
  12. Subjects who eat food containing caffeine or grapefruit or drink alcohol in prohibited period
  13. Subjects who are inappropriate in the judgement of the investigator due to the reasons including clinical laboratory test results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954304

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Kyung-Sang Yu, MD., Ph.D Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Kyung-mi Park/ Director, Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT00954304     History of Changes
Other Study ID Numbers: HM-OXL-104
Study First Received: August 6, 2009
Last Updated: September 10, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
Pgp inhibitor
P-glycoprotein inhibitor

Additional relevant MeSH terms:
Krestin
Loperamide
Antidiarrheals
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 11, 2014