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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HM30181AK 60mg; Drug: HM30181AK 15mg; Drug: HM30181AK 1mg; Drug: HM30181AK 5mg; Drug: Loperamide 2mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00954304

HM-OXL-104

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

1mg group

Experimental group

Description:

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

Treatment:

Drug: Loperamide 2mg

Drug: HM30181AK 1mg

5mg group

Experimental group

Description:

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

Treatment:

Drug: Loperamide 2mg

Drug: HM30181AK 5mg

10mg group

Experimental group

Description:

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

Treatment:

Drug: Loperamide 2mg

Drug: HM30181AK 5mg

15mg group

Experimental group

Description:

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

Treatment:

Drug: Loperamide 2mg

Drug: HM30181AK 15mg

60mg group

Experimental group

Description:

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

Treatment:

Drug: Loperamide 2mg

Drug: HM30181AK 60mg