Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet

NCT00954304 | Completed Phase 1

• 1 other identifier: HM-OXL-104
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Pgp inhibitor; P-glycoprotein inhibitor

Outcome Measures

Primary Outcomes (1)

• Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement.

  Day 1~Day 18

Secondary Outcomes (1)

• Evaluate the PK parameters (Cmax, AUClast, AUCinf, Tmax, T1/2, CL/F etc) of HM30181AK by measuring the blood concentration of HM30181AK

  Day 4

Study Arms (5)

1mg group

EXPERIMENTAL

Administration of HM30181AK 1mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15

Drug: HM30181AK 1mg; Drug: Loperamide 2mg

5mg group

EXPERIMENTAL

Administration of HM30181AK 5mg on day 4 and Loperamide 16mg(Loperamide 2mg x 8cap) on day 1,4,8,11,15

Drug: HM30181AK 5mg; Drug: Loperamide 2mg

10mg group

EXPERIMENTAL

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; Drug: Loperamide 2mg

15mg group

EXPERIMENTAL

Administration of HM30181AK 15mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15

Drug: HM30181AK 15mg; Drug: Loperamide 2mg

60mg group

EXPERIMENTAL

Administration of HM30181AK 60mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15

Drug: HM30181AK 60mg; Drug: Loperamide 2mg

Interventions

HM30181AK 1mg DRUG

HM30181AK 1mg tablet

1mg group

HM30181AK 5mg DRUG

HM30181AK 5mg tablet

10mg group; 5mg group

HM30181AK 15mg DRUG

HM30181AK 15mg tablet

15mg group

HM30181AK 60mg DRUG

HM30181AK 60mg tablet

60mg group

Loperamide 2mg DRUG

Loperamide 2mg capsule

10mg group; 15mg group; 1mg group; 5mg group; 60mg group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers aged 20 to 50 years at screening
• 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
• 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

You may not qualify if:

• Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system.
• 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).
• The following results in laboratory test
• AST, ALT \> 1.25 x upper limits of normal
• Systolic blood pressure below 100 mmHg or above 150 mmHg or diastolic blood pressure below 65 mmHg or above 95 mmHg in vital signs
• History of drug allergy or other allergies which are clinically significant
• History of drug abuse or positive reaction for drug abuse in urine screening test
• 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.)
• Subjects who have participated in other clinical trial within 2 months prior to the first day of drug administration
• 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
• Subject who are continuously drinking alcohol (over 21 units/week) or who cannot quit drinking during clinical trial period
• Subject who are smoking over 10 cigar/day
• Subjects who eat food containing caffeine or grapefruit or drink alcohol in prohibited period
• Subjects who are inappropriate in the judgement of the investigator due to the reasons including clinical laboratory test results

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Loperamide

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kyung-Sang Yu, MD., Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 7, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 13, 2010

Record last verified: 2010-09

Locations

KR (1)