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

NCT03235362 | Completed Phase 1

• 1 other identifier: YH14755-103
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Dyslipidemia; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• YHR1705, YHR1706 AUCtau

  AUCtau

  0 - 24hours

• YHR1705, YHR1706 Css, max

  Css,max

  0 - 24hours

Study Arms (6)

1

EXPERIMENTAL

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; Drug: YHR1706; Drug: YHR1705+YHR1706

2

EXPERIMENTAL

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; Drug: YHR1706; Drug: YHR1705+YHR1706

3

EXPERIMENTAL

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; Drug: YHR1706; Drug: YHR1705+YHR1706

4

EXPERIMENTAL

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; Drug: YHR1706; Drug: YHR1705+YHR1706

5

EXPERIMENTAL

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; Drug: YHR1706; Drug: YHR1705+YHR1706

6

EXPERIMENTAL

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; Drug: YHR1706; Drug: YHR1705+YHR1706

Interventions

YHR1705 DRUG

Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.

1; 2; 3; 4; 5; 6

YHR1706 DRUG

Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.

1; 2; 3; 4; 5; 6

YHR1705+YHR1706 DRUG

Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 19 Years - 55 Years
• Gender Eligibility Details: Healthy male with body mass index (BMI) between 18.5kg/m2 and 30kg/m2
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Mingul Kim, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 1, 2017
• Study Start: August 7, 2017
• Primary Completion: September 19, 2017
• Study Completion: September 19, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)