Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Male Subjects

A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of HIP1601 40 mg in Healthy Volunteers

Primary objective

- To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

Secondary objectives

• To explore food effect on the pharmacodynamics (PD) of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
• To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

Study Overview

• Status: Completed
• Conditions: Heathy Volunteer
• Intervention / Treatment: Drug: HIP1601 40mg

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Biomedical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male/Female healthy volunteers in the age between 19 and 50 years old.
• Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
• Helicobacter pylori (H. Pylori) negative.
• After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
• Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

Exclusion Criteria:

• Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
• Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to esomeprazole or the same component or other drugs (aspirin, antibiotics, etc.).
• Blood serum aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
• Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
• Heavy smoker (>10 cigarettes/day).

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601	Drug: HIP1601 40mg; Single dosing of HIP1601 40mg, orally; Other Names: HIP1601
Experimental: Sequence 2; Period 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601	Drug: HIP1601 40mg; Single dosing of HIP1601 40mg, orally; Other Names: HIP1601

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed concentration after dose	Blood sampling during 24 hours after administration
Area Under the plasma concentration versus time Curve(AUC)last	Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration	Blood sampling during 24 hours after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time of Cmax over the time span specified	Blood sampling during 24 hours after administration
AUCinf	Area under the plasma concentration versus time curve from the time of dosing to time extrapolated to infinitely	Blood sampling during 24 hours after administration
t1/2	Terminal half-life	Blood sampling during 24 hours after administration
Clearance/F	Apparent total body clearance after extravascular administration, calculated as Dose/AUCinf	Blood sampling during 24 hours after administration
Vd/F	Apparent volume of distribution after extravascular administration, calculated as Dose/(λzㆍAUCinf)	Blood sampling during 24 hours after administration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integrated gastric acidity for 24-hour	Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose	Blood sampling during 24 hours after administration
Duration of time intra-gastric pH 4.0 or higher	Percent of time with intra-gastric pH greater than 4.0 for 24-hour interval after dose	Blood sampling during 24 hours after administration
Median pH	Median intra-gastric pH for 24-hour interval after dose	Blood sampling during 24 hours after administration
Integrated gastric acidity by time interval	Percent decrease from baseline in integrated gastric acidity after dose by time intervals	Blood sampling during 24 hours after administration

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Jang In-Jin, MD, Seoul National University Hospital, Seoul, Korea

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Actual): August 28, 2019
• Study Completion (Actual): August 28, 2019

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HM-ESOM-102

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