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

A Phase 1, Randomized, Open-label, Multiple-dose, 3-treatment, 6-sequence, 3-period Crossover Clinical Trial to Investigate the Safety and Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706 in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Dyslipidemia
• Intervention / Treatment: Drug: YHR1705; Drug: YHR1706; Drug: YHR1705+YHR1706

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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.	Drug: YHR1705; Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.; Drug: YHR1706; Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.; Drug: YHR1705+YHR1706; Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.
Experimental: 2; 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.	Drug: YHR1705; Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.; Drug: YHR1706; Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.; Drug: YHR1705+YHR1706; Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.
Experimental: 3; 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.	Drug: YHR1705; Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.; Drug: YHR1706; Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.; Drug: YHR1705+YHR1706; Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.
Experimental: 4; 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.	Drug: YHR1705; Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.; Drug: YHR1706; Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.; Drug: YHR1705+YHR1706; Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.
Experimental: 5; 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.	Drug: YHR1705; Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.; Drug: YHR1706; Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.; Drug: YHR1705+YHR1706; Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.
Experimental: 6; 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.	Drug: YHR1705; Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.; Drug: YHR1706; Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.; Drug: YHR1705+YHR1706; Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
YHR1705, YHR1706 AUCtau	AUCtau	0 - 24hours
YHR1705, YHR1706 Css, max	Css,max	0 - 24hours

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Mingul Kim, MD, Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): September 19, 2017
• Study Completion (Actual): September 19, 2017

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Diabetes Mellitus, Type 2; Dyslipidemias
• Other Study ID Numbers: YH14755-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No