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

Phase 1

Completed

• Conditions: Dyslipidemia; Type 2 Diabetes Mellitus
• Interventions: Drug: YHR1705; Drug: YHR1706; Drug: YHR1705+YHR1706

• Registration Number: NCT03235362
• Lead Sponsor: Yuhan Corporation

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-08-01
• Study Start: 2017-08-07
• Primary Completion: 2017-09-19
• Study Completion: 2017-09-19
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	YHR1705+YHR1706	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.
2	YHR1705	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.
1	YHR1705	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.
1	YHR1706	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.
2	YHR1705+YHR1706	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.
3	YHR1706	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.
3	YHR1705	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.
3	YHR1705+YHR1706	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.
4	YHR1705	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.
2	YHR1706	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.
5	YHR1705	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.
6	YHR1706	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.
6	YHR1705+YHR1706	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.
5	YHR1706	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.
4	YHR1706	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.
4	YHR1705+YHR1706	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.
5	YHR1705+YHR1706	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.
6	YHR1705	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.

Primary Outcome Measures

Name	Time	Method
YHR1705, YHR1706 AUCtau	0 - 24hours	AUCtau
YHR1705, YHR1706 Css, max	0 - 24hours	Css,max

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of