HealthyPhase 1NCT03220399
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2
A Phase 1 study testing NVP-1603-1 (P), NVP-1603-2 (T) and NVP-1603-1 and NVP-1603-2 (P+T) in people with Healthy, run by NVP Healthcare.
Trial summary
The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2 Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NVP-1603-1 (P), NVP-1603-2 (T) and NVP-1603-1 and NVP-1603-2 (P+T)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 31 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men 19years of age or older at screening test.
- BMI of >18.5kg/㎡ and <27.0kg/㎡ subject, weight more than 50kg.
- Subject has signed and dated informed consent.
Who cannot join
- Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
- History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
- Current alcohol abuse.
About this study
Official title: Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2 in Healthy Male Volunteers
The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2
Read the detailed description
pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2
- Conditions
- Healthy
- Being tested
- NVP-1603-1 (P), NVP-1603-2 (T), NVP-1603-1 and NVP-1603-2 (P+T)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVP-1603-1 (P)Drug
Also called NVP-1603-1
1capsule, single oral dosing
NVP-1603-2 (T)Drug
Also called NVP-1603-2
1tablet, single oral dosing
NVP-1603-1 and NVP-1603-2 (P+T)Drug
Also called NVP-1603-1 and NVP-1603-2
1capsule and 1tablet co-administration, oral single dosing
| Study group | Role | What they receive |
|---|---|---|
| NVP-1603-1 (P) | Experimental | Drug: NVP-1603-1
1capsule, oral dosing Receives: Drug: NVP-1603-1 (P) |
| NVP-1603-2(T) | Experimental | Drug: NVP-1603-2
1Tablet, oral dosing Receives: Drug: NVP-1603-2 (T) |
| NVP-1603-1and NVP-1603-2 (P+T) | Experimental | Drug: NVP-1603-1, 1capsule and NVP-1603-2, 1Tablet co-adminstration (oral dosing) Receives: Drug: NVP-1603-1 and NVP-1603-2 (P+T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic interaction
Area under the curve (AUC)
Measured: 0h - 48hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Dec 2019 (estimated)
- Primary completion28 Mar 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Why it stopped: Decided to stop drug development
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NVP Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220399
- Sponsor's protocol ID
- NVP-1603_P1_DDI
- Status last verified
- Aug 2019
- First submitted
- 30 Jun 2017
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03220399
- Acronym / sponsor ID
- NVP-1603_P1_DDI
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decided to stop drug development
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NVP HealthcareIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 28 Mar 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 18 Jul 2017 (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/tolerability between NVP-1603-1 and NVP-1603-2
Detailed description
pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NVP-1603-1 (P) | Experimental | Drug: NVP-1603-1 (P)Drug: NVP-1603-1 1capsule, oral dosing |
| NVP-1603-2(T) | Experimental | Drug: NVP-1603-2 (T)Drug: NVP-1603-2 1Tablet, oral dosing |
| NVP-1603-1and NVP-1603-2 (P+T) | Experimental | Drug: NVP-1603-1 and NVP-1603-2 (P+T)Drug: NVP-1603-1, 1capsule and NVP-1603-2, 1Tablet co-adminstration (oral dosing) |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men 19years of age or older at screening test.
- BMI of >18.5kg/㎡ and <27.0kg/㎡ subject, weight more than 50kg.
- Subject has signed and dated informed consent.
Key exclusion criteria (3 listed)
- Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
- History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
- Current alcohol 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 |
|---|---|---|
| NVP-1603-1 (P)Also: NVP-1603-11capsule, single oral dosing | Drug | NVP-1603-1 (P) |
| NVP-1603-2 (T)Also: NVP-1603-21tablet, single oral dosing | Drug | NVP-1603-2(T) |
| NVP-1603-1 and NVP-1603-2 (P+T)Also: NVP-1603-1 and NVP-1603-21capsule and 1tablet co-administration, oral single dosing | Drug | NVP-1603-1and NVP-1603-2 (P+T) |
Primary outcome
Pharmacokinetic interaction
Time frame: 0h - 48hrs
Area under the curve (AUC)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NVP-1603-1 (P), NVP-1603-2 (T) and NVP-1603-1 and NVP-1603-2 (P+T) in people with Healthy, run by NVP Healthcare.
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: withdrawn, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetic interaction (time frame: 0h - 48hrs). 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 26 Aug 2019.