Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers

NCT04654078 | Completed Phase 1

• 1 other identifier: IN_KOD_102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the pharmacokinetic characteristics and safety of IN-C004 in healthy volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• AUCt of tegoprazan

  Area under the plasma concentration-time curve of tegoprazan

  pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

• Cmax of tegoprazan

  Maximum Plasma Concentration at Steady State of tegoprazan

  pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

• AUCt of tegoprazan metabolite M1

  Area under the plasma concentration-time curve of tegoprazan metabolite M1

  pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hour

• Cmax of tegoprazan metabolite M1

  Maximum Plasma Concentration at Steady State of tegoprazan metabolite M1

  pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

Study Arms (6)

Group 1

EXPERIMENTAL

Group 1

Drug: IN-C004 with water; Drug: IN-C004 without water; Drug: K-CAB tab. with water

Group 2

EXPERIMENTAL

Group 2

Drug: IN-C004 with water; Drug: IN-C004 without water; Drug: K-CAB tab. with water

Group 3

EXPERIMENTAL

Group 3

Drug: IN-C004 with water; Drug: IN-C004 without water; Drug: K-CAB tab. with water

Group 4

EXPERIMENTAL

Group 4

Drug: IN-C004 with water; Drug: IN-C004 without water; Drug: K-CAB tab. with water

Group 5

EXPERIMENTAL

Group 5

Drug: IN-C004 with water; Drug: IN-C004 without water; Drug: K-CAB tab. with water

Group 6

EXPERIMENTAL

Group 6

Drug: IN-C004 with water; Drug: IN-C004 without water; Drug: K-CAB tab. with water

Interventions

IN-C004 with water DRUG

One time dose of IN-C004 taken with water

Also known as: IN-C004

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

IN-C004 without water DRUG

One time dose of IN-C004 taken without water

Also known as: IN-C004

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

K-CAB tab. with water DRUG

One time dose of K-CAB tab. taken with water

Also known as: K-CAB tab.

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

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

You may qualify if:

• Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening.

You may not qualify if:

• History or evidence of clinically significant disease
• History of drug/alcohol abuse
• Participated in other studies and received investigational products within 6 months prior to the first study dose.
• AST(GOT) or ALT(GPT) \> 2 X upper limit of normal at screening
• Not able to use a medically acceptable contraceptive method throughout the study.

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Min-Gul Kim

  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: November 29, 2020
• First Posted: December 4, 2020
• Study Start: January 18, 2021
• Primary Completion: February 5, 2021
• Study Completion: February 15, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

KR (1)