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

NCT03882112 | Completed Phase 1

• 1 other identifier: HM-ESOM-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heathy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Other Outcomes (4)

• Integrated gastric acidity for 24-hour

  Blood sampling during 24 hours after administration

• Duration of time intra-gastric pH 4.0 or higher

  Blood sampling during 24 hours after administration

• Median pH

  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, orally

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

• Jang In-Jin, 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: March 18, 2019
• First Posted: March 20, 2019
• Study Start: April 17, 2019
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)