Healthy SubjectsPhase 1NCT05023031
Evaluation of Pharmacokinetic and Safety of NVP-2102 and NVP-2102-R in Healthy Subjects
A Phase 1 study testing NVP-2102 and NVP-2102-R in people with Healthy Subjects, run by NVP Healthcare at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- NVP-2102 and NVP-2102-R
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Oct 2021to 15 Jan 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject, 19 years of age or older
- Subjects who signed informed consent
- Body mass index(BMI) of 18 to 30.0 kg/㎡
Who cannot join
- Subject who has clinically significant medical history
- Inadequate subject for the clinical trial by the investigator's decision
- Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety After Oral Administration of NVP-2102 and NVP-2102-R in Healthy Subjects
The purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R.
Read the detailed description
Evaluate the pharmacokinetics and safety of NVP-2102 compared to NVP-2102-R
- Conditions
- Healthy Subjects
- Being tested
- NVP-2102, NVP-2102-R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVP-2102Drug
Tablet formulation for oral administration, single dose of NVP-2102 at Day 1
NVP-2102-RDrug
Tablet formulation for oral administration, single dose of NVP-2102-R at Day 1
| Study group | Role | What they receive |
|---|---|---|
| NVP-2102 | Experimental | NVP-2102 Receives: Drug: NVP-2102 |
| NVP-2102-R | Active comparator | NVP-2102-R Receives: Drug: NVP-2102-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Area under the plasma drug concentration-time curve(AUCt)
Pharmacokinetics parameter derived from plasma
Measured: 0 ~ 72 hours
Evaluation of Maximum observed plasma concentration(Cmax)
Pharmacokinetics parameter derived from plasma
Measured: 0 ~ 72 hours
Secondary outcomes (6)
Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)
Pharmacokinetics parameter derived from plasma
Measured: 0 ~ 72 hours
Evaluation of AUCt/AUC∞
Pharmacokinetics parameter derived from plasma
Measured: 0 ~ 72 hours
Evaluation of Time of peak concentration(Tmax)
Pharmacokinetics parameter derived from plasma
Measured: 0 ~ 72 hours
Evaluation of Terminal phase of Half-life(t1/2)
Pharmacokinetics parameter derived from plasma
Measured: 0 ~ 72 hours
Evaluation of total clearance of the drug from plasma after oral administration(CL/F)
Pharmacokinetics parameter derived from plasma
Measured: 0 ~ 72 hours
Evaluation of volume of distribution after non-intravenous administration(Vz/F)
Pharmacokinetics parameter derived from plasma
Measured: 0 ~ 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start5 Oct 2021
- Primary completion24 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- NVP Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Woo Kim, Principal investigator, H+ Yangji hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023031
- Sponsor's protocol ID
- NVP-2102_BE
- Status last verified
- Jan 2022
- First submitted
- 5 Jul 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety After Oral Administration of NVP-2102 and NVP-2102-R in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05023031
- Acronym / sponsor ID
- NVP-2102_BE
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- NVP HealthcareIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 26 Aug 2021 (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 purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R.
Detailed description
Evaluate the pharmacokinetics and safety of NVP-2102 compared to NVP-2102-R
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVP-2102 | Experimental | Drug: NVP-2102NVP-2102 |
| NVP-2102-R | Active comparator | Drug: NVP-2102-RNVP-2102-R |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subject, 19 years of age or older
- Subjects who signed informed consent
- Body mass index(BMI) of 18 to 30.0 kg/㎡
Key exclusion criteria (3 listed)
- Subject who has clinically significant medical history
- Inadequate subject for the clinical trial by the investigator's decision
- Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product
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 |
|---|---|---|
| NVP-2102Tablet formulation for oral administration, single dose of NVP-2102 at Day 1 | Drug | NVP-2102 |
| NVP-2102-RTablet formulation for oral administration, single dose of NVP-2102-R at Day 1 | Drug | NVP-2102-R |
Primary outcome
Evaluation of Area under the plasma drug concentration-time curve(AUCt)
Time frame: 0 ~ 72 hours
Pharmacokinetics parameter derived from plasma
Evaluation of Maximum observed plasma concentration(Cmax)
Time frame: 0 ~ 72 hours
Pharmacokinetics parameter derived from plasma
6 secondary outcomes
Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)
Time frame: 0 ~ 72 hours
Evaluation of AUCt/AUC∞
Time frame: 0 ~ 72 hours
Evaluation of Time of peak concentration(Tmax)
Time frame: 0 ~ 72 hours
Evaluation of Terminal phase of Half-life(t1/2)
Time frame: 0 ~ 72 hours
Evaluation of total clearance of the drug from plasma after oral administration(CL/F)
Time frame: 0 ~ 72 hours
Evaluation of volume of distribution after non-intravenous administration(Vz/F)
Time frame: 0 ~ 72 hours
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 19 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Jae Woo Kim principal investigator
H+ Yangji 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 NVP-2102 and NVP-2102-R in people with Healthy Subjects, run by NVP Healthcare 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 3 inclusion and 3 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 19 Jan 2022. 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?
Evaluation of Area under the plasma drug concentration-time curve(AUCt) (time frame: 0 ~ 72 hours). 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 19 Jan 2022.