HealthyPhase 1NCT04486157
Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
A Phase 1 study testing IN-A012 and Akynzeo 300Mg-0.5Mg Capsule in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IN-A012 and Akynzeo 300Mg-0.5Mg Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Mar 2021to 10 May 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged between 19-45
- Body weight ≥ 50kg and in the range of ideal body weight ± 20%
- Without congenital, or chronic diseases within recent 5 years
- Subjects who are deemed eligible based on the screening tests
- Subjects who received a full explanation of the study, understood the purpose and details of this study, characteristics of the investigational product, and expected adverse events, and voluntarily signed the informed consent form
- Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product
- Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions.
Who cannot join
- A subject with symptoms suspected of acute illness at the screening
- A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors
- A history of gastrointestinal disease
- Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity
- A history of drug abuse
- Pregnant women or women who may be pregnant, and breastfeeding women
- Subjects who are deemed inappropriate to participate in the study by the investigator for other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Crossover Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation
Read the detailed description
[Pharmacokinetics Assessment]
- Primary Parameter
- AUC0-t
- Secondary Parameters - Cmax, tmax
[Safety Assessment]
- Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests
- Conditions
- Healthy
- Being tested
- IN-A012, Akynzeo 300Mg-0.5Mg Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-A012Drug
The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.
Akynzeo 300Mg-0.5Mg CapsuleDrug
The subjects will be administrated Akynzeo by Orally with water.
| Study group | Role | What they receive |
|---|---|---|
| IN-A012 | Experimental | Intravenous administration of IN-A012 Receives: Drug: IN-A012 |
| Akynzeo capsules | Active comparator | Single oral administration of Akynzeo capsules Receives: Drug: Akynzeo 300Mg-0.5Mg Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t of netupitant
Area under the plasma concentration versus time curve of netupitant
Measured: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
Secondary outcomes (2)
Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron
Peak Plasma Concentration of fosnetupitant, netupitant metabolites and palonosetron
Measured: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
tmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron
Time to reach maximum (peak) plasma concentration of fosnetupitant, netupitant, netupitant metabolites and palonosetron
Measured: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start18 Mar 2021
- Primary completion26 Apr 2021
- Study completion10 May 2021
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seunghoon Han, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486157
- Sponsor's protocol ID
- IN_FNP_101
- Status last verified
- May 2021
- First submitted
- 17 Jul 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Crossover Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
- ClinicalTrials.gov ID
- NCT04486157
- Acronym / sponsor ID
- IN_FNP_101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 24 Jul 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.
The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation
Detailed description
[Pharmacokinetics Assessment]
- Primary Parameter
- AUC0-t
- Secondary Parameters - Cmax, tmax
[Safety Assessment]
- Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IN-A012 | Experimental | Drug: IN-A012Intravenous administration of IN-A012 |
| Akynzeo capsules | Active comparator | Drug: Akynzeo 300Mg-0.5Mg CapsuleSingle oral administration of Akynzeo capsules |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults aged between 19-45
- Body weight ≥ 50kg and in the range of ideal body weight ± 20%
- Without congenital, or chronic diseases within recent 5 years
- Subjects who are deemed eligible based on the screening tests
- Subjects who received a full explanation of the study, understood the purpose and details of this study, characteristics of the investigational product, and expected adverse events, and voluntarily signed the informed consent form
Key exclusion criteria (7 listed)
- A subject with symptoms suspected of acute illness at the screening
- A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors
- A history of gastrointestinal disease
- Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity
- A history of drug abuse
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 |
|---|---|---|
| IN-A012The subjects will be given IN-A012 by Intravenous infusion over 30 minutes. | Drug | IN-A012 |
| Akynzeo 300Mg-0.5Mg CapsuleThe subjects will be administrated Akynzeo by Orally with water. | Drug | Akynzeo capsules |
Primary outcome
AUC0-t of netupitant
Time frame: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
Area under the plasma concentration versus time curve of netupitant
2 secondary outcomes
Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron
Time frame: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
tmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron
Time frame: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
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 Jun 2021.
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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.
Seunghoon Han principal investigator
The Catholic University of Korea
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 IN-A012 and Akynzeo 300Mg-0.5Mg Capsule 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 7 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 1 Jun 2021. 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?
AUC0-t of netupitant (time frame: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose). 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 Jun 2021.