A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03530228
Collaborator
(none)
44
1
7
3
14.6

Study Details

Study Description

Brief Summary

A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects

Condition or Disease Intervention/Treatment Phase
  • Drug: Tegoprazan (C1)
  • Drug: Tegoprazan (C1)
  • Drug: Treatment C: Tegoprazan (C1)
  • Drug: Tegoprazan (C2)
  • Drug: Tegoprazan (C2)
  • Drug: Esomeprazole (C2)
  • Drug: Tegoprazan (C3)
Phase 1

Detailed Description

  • To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males.

  • To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males.

  • To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Cohort 1: crossover Cohort 2: parallel Cohort 3: single groupCohort 1: crossover Cohort 2: parallel Cohort 3: single group
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Open-label, Active-controlled, Single/Multiple-dose Phase 1 Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Tegoprazan After Oral Administration in Healthy Male Subjects
Anticipated Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2018
Anticipated Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A: Tegoprazan (C1)

Tegoprazan QD, oral administration

Drug: Tegoprazan (C1)
Tegoprazan QD, oral administration. Treatment A

Experimental: Treatment B: Tegoprazan (C1)

Tegoprazan QD, oral administration

Drug: Tegoprazan (C1)
Tegoprazan QD, oral administration. Treatment B

Experimental: Treatment C: Tegoprazan (C1)

Tegoprazan BID, oral administration

Drug: Treatment C: Tegoprazan (C1)
Tegoprazan BID, oral administration

Experimental: Group 1: Tegoprazan (C2)

Tegoprazan QD, oral administration, for 7 days

Drug: Tegoprazan (C2)
Tegoprazan QD, oral administration, for 7 days. Group 1

Experimental: Group 2: Tegoprazan (C2)

Tegoprazan QD, oral administration, for 7 days

Drug: Tegoprazan (C2)
Tegoprazan QD, oral administration, for 7 days. Group 2

Active Comparator: Group 3: Esomeprazole (C2)

Esomeprazole QD, oral administration, for 7 days

Drug: Esomeprazole (C2)
Esomeprazole QD, oral administration, for 7 days. Group 3

Experimental: Tegoprazan (C3)

Tegoprazan QD, oral administration

Drug: Tegoprazan (C3)
Tegoprazan QD, oral administration

Outcome Measures

Primary Outcome Measures

  1. AUC(0-24h) of tegoprazan [up to 7 days]

    Area Under the Curve(0-24h) of tegoprazan

  2. Cmax of tegoprazan [up to 7 days]

    Maximum Plasma Concentration of tegoprazan

  3. Gastric pH [up to 7 days]

    Gastric pH

  4. Serum gastrin concentration [up to 7 days]

    Serum gastrin concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy adult males aged ≥ 19 years and ≤ 50 years

  • Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening

Exclusion Criteria:
  • Presence or history of clinically significant diseases

  • Presence or history of gastrointestinal disorder (gastric ulcer, GERD, - Crohn's disease, etc.)

  • Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity

  • Serologic test positive

  • Abnormal obstacle to insertion and maintenance of pH meter catheter

  • History of drug abuse

  • Excessive caffeine intake or persistent alcohol intake

  • Not use of a medically acceptable method of contraception

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • HK inno.N Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HK inno.N Corporation
ClinicalTrials.gov Identifier:
NCT03530228
Other Study ID Numbers:
  • CJ_APA_109
First Posted:
May 21, 2018
Last Update Posted:
May 21, 2018
Last Verified:
May 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 21, 2018