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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00954304

Acronym

PGP inhibitor

Enrollment

Registered

2009-08-07

Start date

2009-06-30

Completion date

2009-09-30

Last updated

2010-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pgp inhibitor, P-glycoprotein inhibitor

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.

Interventions

DRUGHM30181AK 1mg

HM30181AK 1mg tablet

DRUGHM30181AK 5mg

HM30181AK 5mg tablet

DRUGHM30181AK 15mg

HM30181AK 15mg tablet

DRUGHM30181AK 60mg

HM30181AK 60mg tablet

DRUGLoperamide 2mg

Loperamide 2mg capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement.	Day 1~Day 18

Secondary

Measure	Time frame
Evaluate the PK parameters (Cmax, AUClast, AUCinf, Tmax, T1/2, CL/F etc) of HM30181AK by measuring the blood concentration of HM30181AK	Day 4

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026