Safety IssuesPhase 1NCT03565861
Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers
A Phase 1 study testing NP10679 in people with Safety Issues, run by Neurop Inc. at 1 site in United States.
Trial summary
This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- NP10679
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2018to 10 Oct 2018
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects aged 18 to 55 years
- Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
- If of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study.
Who cannot join
- Clinical laboratory values greater than or equal to 2 times the upper limit of normal.
- Recent history (within 2 yrs) or current tobacco use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized , Double Blind, Single Ascending Dose Study to Investigate Safety, Tolerability and PK of NP10679 in Healthy Adults
This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.
Read the detailed description
NP10679 is a pH dependent inhibitor of the GluN2B subtype of the NMDA receptor. Compounds of this drug class are hypothesized to be beneficial in a number of central nervous system disorders, including brain ischemia associated with subarachnoid hemorrhage, severe pain, major depression and substance abuse disorders. This study uses a double blind, adaptive design approach to evaluate the safety, tolerability and pharmacokinetics of a single dose of NP10679 when delivered intravenously in up to six escalating dose levels in comparison to placebo.
- Conditions
- Safety Issues
- Being tested
- Placebo, NP10679
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Intravenous vehicle
NP10679Drug
NP10679
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo intravenous 30 minute infusion on day 1 Receives: Drug: Placebo |
| NP10679 5 mg | Experimental | NP10679 5 mg intravenous infusion on day 1 Receives: Drug: NP10679 |
| NP10679 15 mg | Experimental | NP10679 15 mg intravenous infusion on day 1 Receives: Drug: NP10679 |
| NP10679 50 mg | Experimental | NP10679 50 mg intravenous infusion on day 1 Receives: Drug: NP10679 |
| NP10679 100 mg | Experimental | NP10679 100 mg intravenous infusion on day 1 Receives: Drug: NP10679 |
| NP10679 200 mg | Experimental | NP10679 200 mg intravenous infusion on day 1 Receives: Drug: NP10679 |
| NP10679 300 mg | Experimental | NP10679 300 mg intravenous infusion on day 1 Receives: Drug: NP10679 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events as a measure of safety and tolerability
Observed side effects and alteration in laboratory values.
Measured: 8 days
Secondary outcomes (1)
Plasma concentration of parent drug
Cmax after administration.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start6 Apr 2018
- Primary completion2 Sep 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Sequential
- Model description
- Adaptive design of placebo and up to six escalating doses of NP10679
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurop Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Zaczek, Ph.D., Study chair, Neurop Inc.Paolo DePetrillo, Principal investigator, Pharmaron CPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565861
- Sponsor's protocol ID
- NP10679-001
- Status last verified
- Mar 2019
- First submitted
- 29 May 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized , Double Blind, Single Ascending Dose Study to Investigate Safety, Tolerability and PK of NP10679 in Healthy Adults
- ClinicalTrials.gov ID
- NCT03565861
- Acronym / sponsor ID
- NP10679-001
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Neurop Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 2 Sep 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 21 Jun 2018 (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 assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.
Detailed description
NP10679 is a pH dependent inhibitor of the GluN2B subtype of the NMDA receptor. Compounds of this drug class are hypothesized to be beneficial in a number of central nervous system disorders, including brain ischemia associated with subarachnoid hemorrhage, severe pain, major depression and substance abuse disorders. This study uses a double blind, adaptive design approach to evaluate the safety, tolerability and pharmacokinetics of a single dose of NP10679 when delivered intravenously in up to six escalating dose levels in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Adaptive design of placebo and up to six escalating doses of NP10679
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo intravenous 30 minute infusion on day 1 |
| NP10679 5 mg | Experimental | Drug: NP10679NP10679 5 mg intravenous infusion on day 1 |
| NP10679 15 mg | Experimental | Drug: NP10679NP10679 15 mg intravenous infusion on day 1 |
| NP10679 50 mg | Experimental | Drug: NP10679NP10679 50 mg intravenous infusion on day 1 |
| NP10679 100 mg | Experimental | Drug: NP10679NP10679 100 mg intravenous infusion on day 1 |
| NP10679 200 mg | Experimental | Drug: NP10679NP10679 200 mg intravenous infusion on day 1 |
| NP10679 300 mg | Experimental | Drug: NP10679NP10679 300 mg intravenous infusion on day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female subjects aged 18 to 55 years
- Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
- If of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study.
Key exclusion criteria (2 listed)
- Clinical laboratory values greater than or equal to 2 times the upper limit of normal.
- Recent history (within 2 yrs) or current tobacco use.
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 |
|---|---|---|
| PlaceboIntravenous vehicle | Drug | Placebo |
| NP10679NP10679 | Drug | NP10679 100 mg, NP10679 15 mg, NP10679 200 mg, NP10679 300 mg, NP10679 5 mg, NP10679 50 mg |
Primary outcome
Incidence of adverse events as a measure of safety and tolerability
Time frame: 8 days
Observed side effects and alteration in laboratory values.
1 secondary outcome
Plasma concentration of parent drug
Time frame: 4 days
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 13 Mar 2019.
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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.
Robert Zaczek, Ph.D. study chair
Neurop Inc.
Paolo DePetrillo principal investigator
Pharmaron CPC
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 NP10679 in people with Safety Issues, run by Neurop Inc. at 1 site in United States.
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 2 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 13 Mar 2019. 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 United States. 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?
Incidence of adverse events as a measure of safety and tolerability (time frame: 8 days). 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 13 Mar 2019.