HealthyPhase 1NCT04221321
Effect of Tegoprazan or RAPA114 on Pharmacokinetic of Atorvastatin in Healthy Adult Volunteers
A Phase 1 study testing Atorvastatin 40 mg, Tegoprazan 50 mg and RAPA114 in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to evaluate the influence of tegoprazan or RAPA114 on the Pharmacokinetic characteristics of atorvastatin following co-administration of tegoprazan or RAPA114 in healthy adult volunteers. 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?
- Atorvastatin 40 mg, Tegoprazan 50 mg and RAPA114
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2020to 20 Apr 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 male adults aged 19 to 55 years (inclusive) at the time of his consent.
- Body mass index (BMI) ≥ 19.0 and ≤ 27.0 kg/m2 at screening.
- Decides to participate voluntarily in the trial after being fully informed of and understanding the study completely, and provides the written informed consent to participate in the trial and to comply with the trial-specific requirements.
- Has the ability and willingness to participate in the entire period of clinical trial.
Who cannot join
- A subject with clinically significant disease or history of hepatobiliary, renal, gastrointestinal, cardiovascular, musculoskeletal, endocrine, respiratory, neuropsychiatry or hemato-oncologic system, etc.
- A subject with a history of hypersensitivity reactions to main constituents of or identical affiliation of the investigational products (ex, HMG-CoA reductase inhibitor, gastric acid suppressants), or have allergic diseases that require treatment.
- A subject with a history of genetic myopathy or family history.
- A subject who has participated in other clinical trials and received the investigational products within 180 days prior to the randomization.
- A subject who received any medications or foods that could significantly affect the absorption, distribution, metabolism, or excretion of an investigational product within 30 days prior to the randomization.
- A subject with history of whole blood donation within 60 days, or with blood components or received transfusion within 30 days prior to the randomization.
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- A subject with continued consumption of alcohol more than 140 g per week.
- A subject with AST, ALT, or γ-GT levels exceeding 1.5 times of the upper limit of the reference range in the screening test.
- A subject with a calculated glomerular filtration rate of less than 60 mL / min / 1.73 m2 in the screening test.
- A subject with any positive result on serology tests for hepatitis B, hepatitis C, HIV or syphilis in the screening test.
- A subject with galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose malabsorption, etc.
- Male subject who don't have willing to accept medically acceptable contraceptive methods during the course of clinical trial, or who plan to provide sperm.
- A subject who is determined to be ineligible to participate in the clinical trial by the investigator for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Multiple-dose, Replicated Crossover Study to Evaluate Drug-drug Interaction Following Co-administration of Tegoprazan or RAPA114 With Atorvastatin in Healthy Adults
This study aims to evaluate the influence of tegoprazan or RAPA114 on the Pharmacokinetic characteristics of atorvastatin following co-administration of tegoprazan or RAPA114 in healthy adult volunteers.
Read the detailed description
[Pharmacokinetic Assessments] : Blood concentration of atorvastatin, 2-OH atorvastatin
- Primary outcome: AUCτ, Css,max of atorvastatin
- Secondary outcome: Tss,max of atorvastatin, AUCτ, Css,max of 2-OH atorvastatin, metabolic ratio
[Sefety Assessments]
: Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
- Conditions
- Healthy
- Being tested
- Atorvastatin 40 mg, Tegoprazan 50 mg, RAPA114
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 40 mgDrug
Also called Lipitor
Atorvastatin 40 mg
Tegoprazan 50 mgDrug
Also called K-CAB
Tegoprazan 50 mg tablet
RAPA114Drug
RAPA114 tablet
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin 40 mg | Placebo comparator | Oral administration of Atorvastatin 40 mg tablet once daily for 7 days Receives: Drug: Atorvastatin 40 mg |
| Atorvastatin 40 mg + Tegoprazan 50 mg | Experimental | Oral administration of Atorvastatin 40 mg tablet and Tegoprazan 50 mg tablet once daily for 7 days Receives: Drug: Atorvastatin 40 mg; Drug: Tegoprazan 50 mg |
| Atorvastatin 40 mg + RAPA114 | Active comparator | Oral administration of Atorvastatin 40 mg tablet and RAPA114 tablet once daily for 7 days Receives: Drug: Atorvastatin 40 mg; Drug: RAPA114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ of atorvastatin
Area under the plasma drug concentration-time curve at steady state
Measured: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Css,max of atorvastatin
Maximum concentration of drug in plasma of atorvastatin at steady state
Measured: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Secondary outcomes (4)
Tss,max of atorvastatin
Time to Cmax at steady state
Measured: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
AUCτ of 2-OH atorvastatin
Area under the plasma drug concentration-time curve at steady state
Measured: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Css,max of 2-OH atorvastatin
Maximum concentration of drug in plasma of 2-OH atorvastatin at steady state
Measured: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
metabolic ratio
AUCτ of 2-OH atorvastatin / AUCτ of atorvastatin
Measured: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start7 Jan 2020
- Primary completion12 Mar 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jung-ryul Kim, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221321
- Sponsor's protocol ID
- IN_APA_114
- Status last verified
- Jun 2020
- First submitted
- 6 Jan 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multiple-dose, Replicated Crossover Study to Evaluate Drug-drug Interaction Following Co-administration of Tegoprazan or RAPA114 With Atorvastatin in Healthy Adults
- ClinicalTrials.gov ID
- NCT04221321
- Acronym / sponsor ID
- IN_APA_114
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 9 Jan 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 influence of tegoprazan or RAPA114 on the Pharmacokinetic characteristics of atorvastatin following co-administration of tegoprazan or RAPA114 in healthy adult volunteers.
Detailed description
[Pharmacokinetic Assessments] : Blood concentration of atorvastatin, 2-OH atorvastatin
- Primary outcome: AUCτ, Css,max of atorvastatin
- Secondary outcome: Tss,max of atorvastatin, AUCτ, Css,max of 2-OH atorvastatin, metabolic ratio
[Sefety Assessments]
: Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 40 mg | Placebo comparator | Drug: Atorvastatin 40 mgOral administration of Atorvastatin 40 mg tablet once daily for 7 days |
| Atorvastatin 40 mg + Tegoprazan 50 mg | Experimental | Drug: Atorvastatin 40 mg, Drug: Tegoprazan 50 mgOral administration of Atorvastatin 40 mg tablet and Tegoprazan 50 mg tablet once daily for 7 days |
| Atorvastatin 40 mg + RAPA114 | Active comparator | Drug: Atorvastatin 40 mg, Drug: RAPA114Oral administration of Atorvastatin 40 mg tablet and RAPA114 tablet once daily for 7 days |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male adults aged 19 to 55 years (inclusive) at the time of his consent.
- Body mass index (BMI) ≥ 19.0 and ≤ 27.0 kg/m2 at screening.
- Decides to participate voluntarily in the trial after being fully informed of and understanding the study completely, and provides the written informed consent to participate in the trial and to comply with the trial-specific requirements.
- Has the ability and willingness to participate in the entire period of clinical trial.
Key exclusion criteria (13 listed)
- A subject with clinically significant disease or history of hepatobiliary, renal, gastrointestinal, cardiovascular, musculoskeletal, endocrine, respiratory, neuropsychiatry or hemato-oncologic system, etc.
- A subject with a history of hypersensitivity reactions to main constituents of or identical affiliation of the investigational products (ex, HMG-CoA reductase inhibitor, gastric acid suppressants), or have allergic diseases that require treatment.
- A subject with a history of genetic myopathy or family history.
- A subject who has participated in other clinical trials and received the investigational products within 180 days prior to the randomization.
- A subject who received any medications or foods that could significantly affect the absorption, distribution, metabolism, or excretion of an investigational product within 30 days prior to the randomization.
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 |
|---|---|---|
| Atorvastatin 40 mgAlso: LipitorAtorvastatin 40 mg | Drug | Atorvastatin 40 mg, Atorvastatin 40 mg + RAPA114, Atorvastatin 40 mg + Tegoprazan 50 mg |
| Tegoprazan 50 mgAlso: K-CABTegoprazan 50 mg tablet | Drug | Atorvastatin 40 mg + Tegoprazan 50 mg |
| RAPA114RAPA114 tablet | Drug | Atorvastatin 40 mg + RAPA114 |
Primary outcome
AUCτ of atorvastatin
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Area under the plasma drug concentration-time curve at steady state
Css,max of atorvastatin
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Maximum concentration of drug in plasma of atorvastatin at steady state
4 secondary outcomes
Tss,max of atorvastatin
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
AUCτ of 2-OH atorvastatin
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Css,max of 2-OH atorvastatin
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
metabolic ratio
Time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
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 1 Dec 2020.
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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.
Jung-ryul Kim principal investigator
Samsung Medical Center
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 Atorvastatin 40 mg, Tegoprazan 50 mg and RAPA114 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 4 inclusion and 13 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 1 Dec 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. Some participants in this study may receive a placebo. 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 atorvastatin (time frame: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period). 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?
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 1 Dec 2020.