A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706

Yuhan

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus; Dyslipidemia

Treatments: Drug: YHR1705+YHR1706; Drug: YHR1706; Drug: YHR1705

Study type: Interventional

Funder types: Industry

Identifiers

NCT03235362

YH14755-103

Details and patient eligibility

About

This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers

Full description

This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive days. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.

Enrollment: 28 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
• Who has not suffered from clinically significant disease
• Provision of signed written informed consent

Exclusion criteria

• History of and clinically significant disease
• A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
• Administration of other investigational products within 3 months prior to the first dosing
• Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 6 patient groups

1

Experimental group

Description:

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.

Treatment:

Drug: YHR1705+YHR1706

Drug: YHR1706

Drug: YHR1705

2

Experimental group

Description:

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.

Treatment:

Drug: YHR1705+YHR1706

Drug: YHR1706

Drug: YHR1705

3

Experimental group

Description:

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.

Treatment:

Drug: YHR1705+YHR1706

Drug: YHR1706

Drug: YHR1705

4

Experimental group

Description:

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.

Treatment:

Drug: YHR1705+YHR1706

Drug: YHR1706

Drug: YHR1705

5

Experimental group

Description:

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.

Treatment:

Drug: YHR1705+YHR1706

Drug: YHR1706

Drug: YHR1705

6

Experimental group

Description:

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.

Treatment:

Drug: YHR1705+YHR1706

Drug: YHR1706

Drug: YHR1705