Stroke, IschemicPhase 1NCT04007263
A Multiple Ascending Dose Study of Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers
A Phase 1 study testing NP10679 in people with Stroke, Ischemic and Pain, Postoperative, run by Neurop Inc. at 1 site in United States.
Trial summary
This multiple ascending dose 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
- Stroke, Ischemic, Pain, Postoperative, Substance Abuse
- 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 10 Oct 2019
- 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, Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of NP10679 in Healthy Adults"
This multiple ascending dose 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 stroke, 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 5 once daily doses of NP10679 when delivered intravenously in three escalating dose levels in comparison to placebo
- Being tested
- Placebo, NP10679
- Keywords
- NMDA, GluN2B
- Medical subject headings
- Ischemic Stroke, Pain, Postoperative, Substance-Related Disorders, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo via 30 minute infusion once daily for 5 days
NP10679Drug
NP10679 25 mg via 30 minute infusion once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo intravenous infusion over 30 minutes, five days of once daily dosing Receives: Drug: Placebo |
| NP10679 25 mg | Experimental | NP10679 25 mg intravenous infusion over 30 minutes, five days of once daily dosing Receives: Drug: NP10679 |
| NP10679 50 mg | Experimental | NP10679 50 mg intravenous infusion over 30 minutes, five days of once daily dosing Receives: Drug: NP10679 |
| NP10679 100 mg | Experimental | NP10679 100 mg intravenous infusion over 30 minutes, five days of once daily dosing 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: 10 days
Plasma concentration of parent drug
Pharmacokinetic parameters during dosing period through 4 days post dosing
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start4 Apr 2019
- Primary completion30 Aug 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurop Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Pharmaron
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007263
- Sponsor's protocol ID
- NP10679-002
- Other IDs
- 3R44NS071657-06
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zaczek R, Traynelis SF, Dingledine R, Koszalka GW, Laskowitz DT. Phase 1 Clinical Results for NP10679, a pH-sensitive GluN2B-selective N-methyl-d-aspartate Receptor Inhibitor. Clin Pharmacol Drug Dev. 2023 Jul;12(7):706-717. doi: 10.1002/cpdd.1217. Epub 2023 Jan 15.
PubMed 36642931
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double Blind, Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of NP10679 in Healthy Adults"
- ClinicalTrials.gov ID
- NCT04007263
- Acronym / sponsor ID
- NP10679-002
- Keywords
- NMDA, GluN2B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Neurop Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Pharmaron
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 5 Jul 2019 (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 multiple ascending dose 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 stroke, 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 5 once daily doses of NP10679 when delivered intravenously in three escalating dose levels in comparison to placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo intravenous infusion over 30 minutes, five days of once daily dosing |
| NP10679 25 mg | Experimental | Drug: NP10679NP10679 25 mg intravenous infusion over 30 minutes, five days of once daily dosing |
| NP10679 50 mg | Experimental | Drug: NP10679NP10679 50 mg intravenous infusion over 30 minutes, five days of once daily dosing |
| NP10679 100 mg | Experimental | Drug: NP10679NP10679 100 mg intravenous infusion over 30 minutes, five days of once daily dosing |
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 |
|---|---|---|
| PlaceboPlacebo via 30 minute infusion once daily for 5 days | Drug | Placebo |
| NP10679NP10679 25 mg via 30 minute infusion once daily for 5 days | Drug | NP10679 100 mg, NP10679 25 mg, NP10679 50 mg |
Primary outcome
Incidence of adverse events as a measure of safety and tolerability
Time frame: 10 days
Observed side effects and alteration in laboratory values
Plasma concentration of parent drug
Time frame: 9 days
Pharmacokinetic parameters during dosing period through 4 days post dosing
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 4 Nov 2019.
- Derived from this study: PubMed 36642931Zaczek R, Traynelis SF, Dingledine R, Koszalka GW, Laskowitz DT. Phase 1 Clinical Results for NP10679, a pH-sensitive GluN2B-selective N-methyl-d-aspartate Receptor Inhibitor. Clin Pharmacol Drug Dev. 2023 Jul;12(7):706-717. doi: 10.1002/cpdd.1217. Epub 2023 Jan 15.
- 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.
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 Stroke, Ischemic and Pain, Postoperative, 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 4 Nov 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: 10 days). 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?
On the ClinicalTrials.gov record for NCT04007263, which also lists 1 linked publication.
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 4 Nov 2019.