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

NCT04204629 | Completed Phase 1

• 1 other identifier: HM-ESOM-103
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective - To evaluate food effect on the pharmacokinetics and the pharmacodynamics (PD) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition. Secondary objectives \- To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (7)

• Tmax

  Blood sampling during 24 hours after administration

• AUCinf

  Blood sampling during 24 hours after administration

• t1/2

  Blood sampling during 24 hours after administration

• Clearance/F

  Blood sampling during 24 hours after administration

• Vd/F

  Blood sampling during 24 hours after administration

Study Arms (2)

Sequence 1

EXPERIMENTAL

Period 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601

Drug: HIP1601 40mg

Sequence 2

EXPERIMENTAL

Period 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601

Drug: HIP1601 40mg

Interventions

HIP1601 40mg DRUG

Single dosing of HIP1601 40mg, PO

Also known as: HIP1601

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Seoul National University Biomedical Research Institute

Seoul, South Korea

Location

Study Officials

• In-Jin Jang, MD

  Seoul National University Hospital, Seoul, Korea

  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: December 17, 2019
• First Posted: December 19, 2019
• Study Start: January 13, 2020
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: November 1, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)