The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects

NCT02176668 | Completed Phase 1 DMC

• 1 other identifier: YH4808-111
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• The Cmax of YH4808

  Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing

  Day 1(Day 35), Day 7(Day 41)

• The AUC0-24h of YH4808

  Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing

  Day 1(Day 35), Day 7(Day 41)

• The AUC0-24h of M3

  Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing

  Day 1(Day 35), Day 7(Day 41)

• The Cmax of M3

  Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing

  Day 1(Day 35), Day 7(Day 41)

Secondary Outcomes (3)

• the arithmetic mean of 24h intragastric pH monitoring

  Day 1(Day7)~Day2(Day8)

• the median of 24h intragastric pH monitoring

  Day 1(Day7)~Day2(Day8)

• The Duration of stomach maintained over pH4 or 5

  Day 1(Day7)~Day2(Day8)

Study Arms (10)

Cohort1-YH4808 NF 100

EXPERIMENTAL

7 days repeat administration of YH4808 New Formulation 100mg after meal

Drug: YH4808 NF 100

Cohort1-YH4808 OF 200

EXPERIMENTAL

(Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 New Formulation 200mg after meal

Drug: YH4808 OF 200; Drug: YH4808 NF 200

Cohort1-YH4808 NF 200

EXPERIMENTAL

(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg after meal

Drug: YH4808 OF 200; Drug: YH4808 NF 200

Cohort1-YH4808 NF 400

EXPERIMENTAL

7 days repeat administration of YH4808 New Formulation 400mg after meal

Drug: YH4808 NF 400

Cohort2-YH4808 NF 100

EXPERIMENTAL

7 days repeat administration of YH4808 New Formulation 100mg before meal

Drug: YH4808 NF 100

Cohort2-YH4808 NF 200

EXPERIMENTAL

(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal

Drug: YH4808 OF 200; Drug: YH4808 NF 200

Cohort2-YH4808 OF 200

EXPERIMENTAL

(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal

Drug: YH4808 OF 200; Drug: YH4808 NF 200

Cohort2-YH4808 NF 400

EXPERIMENTAL

7 days repeat administration of YH4808 New Formulation 400mg before meal

Drug: YH4808 NF 400

Cohort3-YH4808 OF 200

EXPERIMENTAL

(Partial cross over design) 1. 7 days repeat administration of YH4808 Old Formulation 200mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before dinner 2. 7 days repeat administration of YH4808 Old Formulation 200mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before bed

Drug: YH4808 OF 200

Cohort3-YH4808 OF 400

EXPERIMENTAL

(Partial cross over design) 1. 7 days repeat administration of YH4808 Old Formulation 400mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before dinner 2. 7 days repeat administration of YH4808 Old Formulation 400mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before bed

Drug: YH4808 OF 200

Interventions

YH4808 NF 100 DRUG

The number of times : multiple-dose Rout : oral administration

Cohort1-YH4808 NF 100; Cohort2-YH4808 NF 100

YH4808 OF 200 DRUG

The number of times : multiple-dose Rout : oral administration

Cohort1-YH4808 NF 200; Cohort1-YH4808 OF 200; Cohort2-YH4808 NF 200; Cohort2-YH4808 OF 200; Cohort3-YH4808 OF 200; Cohort3-YH4808 OF 400

YH4808 NF 200 DRUG

The number of times : multiple-dose Rout : oral administration

Cohort1-YH4808 NF 200; Cohort1-YH4808 OF 200; Cohort2-YH4808 NF 200; Cohort2-YH4808 OF 200

YH4808 NF 400 DRUG

The number of times : multiple-dose Rout : oral administration

Cohort1-YH4808 NF 400; Cohort2-YH4808 NF 400

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adult age 20 to 55 over 55kg with ideal body weight(BMI) 18.5 \~ 25
• Subject who has no congenital, chronic disease and disease symptoms in medical examination result
• negative to Helicobacter pylori in 13C urea breath test
• Subject who judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first IP administration.
• Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)

You may not qualify if:

• Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement.
• Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of IP.
• Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.)
• pregnant or lactating woman.

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Yonsei Medical Center Severance Hospital Clinical Trials Center

Seoul, South Korea

Location

Study Officials

• Min soo Park, Ph.D, M.D.

  Yonsei Medical Center Severance Hospital Clinical Trials Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 13, 2022

Record last verified: 2015-02

Locations

KR (1)