NCT04639804

Brief Summary

This study aims to evaluate the pharmacokinetic (PK) interaction between tegoprazan and non-steroidal anti-inflammatory drugs (NSAIDs) after given each alone and in their combination in healthy male adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 16, 2020

Last Update Submit

November 20, 2020

Conditions

Healthy

Keywords

drug-drug interactionpharmacokinetic

Outcome Measures

Primary Outcomes (2)

  • AUCτ of tegoprazan and NSAIDs

    Area under the plasma concentration-time curve during a steady-state dosing interval (τ) of tegoprazan and NSAIDs

    pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7

  • Css,max of tegoprazan and NSAIDs

    Maximum Plasma Concentration at Steady State of tegoprazan and NSAIDs

    pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7

Study Arms (3)

Tegoprazan 50 mg

ACTIVE COMPARATOR

Multiple doses of tegoprazan alone once daily (QD) for 7 days

Drug: Tegoprazan

NSAIDs

ACTIVE COMPARATOR

Multiple doses of NSAIDs alone twice daily (BID) for 7 days

Drug: NaproxenDrug: AceclofenacDrug: Celecoxib

Tegoprazan 50 mg + NSAIDs

ACTIVE COMPARATOR

Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days

Drug: TegoprazanDrug: NaproxenDrug: AceclofenacDrug: Celecoxib

Interventions

TegoprazanDRUG

Tegoprazan 50 mg tablet

Also known as: K-CAB
Tegoprazan 50 mgTegoprazan 50 mg + NSAIDs
NaproxenDRUG

Naproxen 500 mg tablet

Also known as: Naxen-F
NSAIDsTegoprazan 50 mg + NSAIDs
AceclofenacDRUG

Aceclofenac 100 mg tablet

Also known as: Airtal
NSAIDsTegoprazan 50 mg + NSAIDs
CelecoxibDRUG

Celecoxib 200 mg capsule

Also known as: Celebrex 200 mg
NSAIDsTegoprazan 50 mg + NSAIDs

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult aged ≥ 19 and \< 55 year-old at screening
  • Body mass index (BMI) ≥ 19.0 kg/m2 and \< 27.0 kg/m2 with a body weight ≥ 55 kg at screening.

You may not qualify if:

  • History or evidence of clinically significant disease
  • History of GI disease or surgery that may affect the absorption of a drug
  • Laboratory test result which falls into the following values( ALT or AST \> 2 × upper limit of normal (ULN))
  • History of regular alcohol consumption exceeding 210 g/week within 6 months
  • Daily use of ≥ 20 cigarettes within 6 months
  • Has taken any investigational agent within 6 months prior to the first dose of IMP
  • Subjects who are considered ineligible to participate in this study at the discretion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

Related Publications (1)

  • Moon SJ, Shin N, Kang M, Kim B, Kim MG. Pharmacokinetic Interactions Between Tegoprazan and Naproxen, Aceclofenac, and Celecoxib in Healthy Korean Male Subjects. Clin Ther. 2022 Jul;44(7):930-944.e1. doi: 10.1016/j.clinthera.2022.06.002. Epub 2022 Jul 1.

    PMID: 35787943DERIVED

MeSH Terms

Interventions

tegoprazanNaproxenaceclofenacCelecoxib

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Min-Gul Kim, MD, PhD

    Chonbuk 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 16, 2020

First Posted

November 23, 2020

Study Start

June 6, 2020

Primary Completion

July 26, 2020

Study Completion

July 29, 2020

Last Updated

November 23, 2020

Record last verified: 2020-11

Locations

KR(1)