CompletedNCT03378284Updated Mar 30, 2018

A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers

A Phase 1 interventional study of Tegoprazan and Revaprazan in Pharmacodynamics and Healthy Male Volunteers, sponsored by HK inno.N Corporation. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-30.

Sponsored by HK inno.N Corporation · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 16
Allocation: Randomized
Ages: 19 Years to 50 Years
Sex: Male

Study summary

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

Read the detailed description

To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers.
To evaluate the safety and tolerability of multiple oral dose of tegoprazan in healthy male volunteers.

Conditions studied

Pharmacodynamics
Healthy Male Volunteers

Who can participate

Ages eligible: 19 Years to 50 Years
Sexes eligible: 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

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 16 participants (actual)

Study arms

Experimental
Tegoprazan(Test drug)
Tegoprazan drug QD for 7 days
Drug: Tegoprazan
Active comparator
Active comparator drug
Active comparator drug QD for 7 days
Drug: Revaprazan

Interventions

DrugTegoprazan
Tegoprazan QD for 7 days
DrugRevaprazan
Revaprazan QD for 7 days

What researchers measure

Primary outcomes

Gastric pH
Gastric pH
Time frame: up to 7 days
Serum gastrin concentration
Serum gastrin concentration
Time frame: up to 9 days

Study locations

1 site

Seoul National University Hospital
Seoul, Korea, Republic of

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03378284
Lead sponsor: HK inno.N Corporation
Responsible party: Sponsor
First posted: Dec 19, 2017
Start date: Dec 10, 2017
Primary completion: Dec 23, 2017
Completion: Jan 16, 2018
Last update: Mar 30, 2018

Study contacts

In Jin Jang, MD, PhD

principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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