HealthyPhase 1NCT04639804
Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers
A Phase 1 study testing Tegoprazan, Naproxen and Aceclofenac in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tegoprazan, Naproxen and Aceclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jun 2020to 29 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Tegoprazan and Non-steroidal Anti-inflammatory Drugs (NSAIDs) After Multiple Oral Dosing in Healthy Male Volunteers
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.
Read the detailed description
A randomized, open-label, multiple-dose, 6-sequence-arm, 3-period cross-over study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprazanDrug
Also called K-CAB
Tegoprazan 50 mg tablet
NaproxenDrug
Also called Naxen-F
Naproxen 500 mg tablet
AceclofenacDrug
Also called Airtal
Aceclofenac 100 mg tablet
CelecoxibDrug
Also called Celebrex 200 mg
Celecoxib 200 mg capsule
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 50 mg | Active comparator | Multiple doses of tegoprazan alone once daily (QD) for 7 days Receives: Drug: Tegoprazan |
| NSAIDs | Active comparator | Multiple doses of NSAIDs alone twice daily (BID) for 7 days Receives: Drug: Naproxen; Drug: Aceclofenac; Drug: Celecoxib |
| Tegoprazan 50 mg + NSAIDs | Active comparator | Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days Receives: Drug: Tegoprazan; Drug: Naproxen; Drug: Aceclofenac; Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ of tegoprazan and NSAIDs
Area under the plasma concentration-time curve during a steady-state dosing interval (τ) of tegoprazan and NSAIDs
Measured: 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
Measured: pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start6 Jun 2020
- Primary completion26 Jul 2020
- Study completion29 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Gul Kim, MD, PhD, Principal investigator, Chonbuk university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639804
- Sponsor's protocol ID
- IN_APA_117
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35787943
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Tegoprazan and Non-steroidal Anti-inflammatory Drugs (NSAIDs) After Multiple Oral Dosing in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT04639804
- Acronym / sponsor ID
- IN_APA_117
- Conditions
- Healthy
- Keywords
- drug-drug interaction, pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 26 Jul 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized, open-label, multiple-dose, 6-sequence-arm, 3-period cross-over study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tegoprazan 50 mg | Active comparator | Drug: TegoprazanMultiple doses of tegoprazan alone once daily (QD) for 7 days |
| NSAIDs | Active comparator | Drug: Naproxen, Drug: Aceclofenac, Drug: CelecoxibMultiple doses of NSAIDs alone twice daily (BID) for 7 days |
| Tegoprazan 50 mg + NSAIDs | Active comparator | Drug: Tegoprazan, Drug: Naproxen, Drug: Aceclofenac, Drug: CelecoxibMultiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TegoprazanAlso: K-CABTegoprazan 50 mg tablet | Drug | Tegoprazan 50 mg, Tegoprazan 50 mg + NSAIDs |
| NaproxenAlso: Naxen-FNaproxen 500 mg tablet | Drug | NSAIDs, Tegoprazan 50 mg + NSAIDs |
| AceclofenacAlso: AirtalAceclofenac 100 mg tablet | Drug | NSAIDs, Tegoprazan 50 mg + NSAIDs |
| CelecoxibAlso: Celebrex 200 mgCelecoxib 200 mg capsule | Drug | NSAIDs, Tegoprazan 50 mg + NSAIDs |
Primary outcome
AUCτ of tegoprazan and NSAIDs
Time frame: pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7
Area under the plasma concentration-time curve during a steady-state dosing interval (τ) of tegoprazan and NSAIDs
Css,max of tegoprazan and NSAIDs
Time frame: pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7
Maximum Plasma Concentration at Steady State of tegoprazan and NSAIDs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Derived from this study: PubMed 35787943Moon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Gul Kim, MD, PhD principal investigator
Chonbuk university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tegoprazan, Naproxen and Aceclofenac in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCτ of tegoprazan and NSAIDs (time frame: pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04639804, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.