Healthy VolunteersPhase 1NCT02834741
Safety, Tolerability, PK of Oral NYX-2925 in Healthy Volunteers
A Phase 1 study testing NYX-2925 in people with Healthy Volunteers, run by Aptinyx at 1 site in United States.
Trial summary
This is a first in human study of NYX-2925. It will evaluate single and multiple ascending doses of NYX-2925 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NYX-2925
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Mar 2017
- 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.
- 18 to 55 years of age, inclusive, at the time of signing the informed consent form (ICF). 55 to 80 years of age for elderly cohort.
- Female subjects with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (e.g., oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study.
- Male subjects and their female sexual partner should use an acceptable method of birth control during the study. Male subjects must agree to use barrier contraception (condom with spermicide), and refrain from sperm donation, from the first dose of study drug until 90 days after the last dose of study drug.
- Clinical laboratory values within normal limits or deemed not clinically significant by the investigator and/or the sponsor.
- 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.
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- Subject is judged to be in good health as determined by the investigator based on the results of a medical history, physical examination (PE), clinical laboratory profile, and electrocardiogram (ECG) performed during the screening period and confirmed prior to dosing.
- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive).
- Normal renal and hepatic function, with calculated creatinine clearance ≥ 90 mL/minute (Cockcroft-Gault Formula) at Screening or ≥ 60 mL/minute only in the case of the elderly cohort.
Who cannot join
- Clinically significant alcohol or other substance abuse within the last 24 months, in the opinion of the investigator; or, unable to abstain from alcoholic beverages during the course of the study.
- Positive screen for alcohol or drugs of abuse (with the exception of a positive result considered by the investigator to be directly attributable to prescription medication approved for subject use): including benzodiazepines, opiates, cocaine, cannabinoids, and amphetamines.
- History of smoking or tobacco use within 30 days of Screening.
- Women who are pregnant, breast feeding, or planning to become pregnant during the course of the study.
- History of allergy, sensitivity, or intolerance to NMDAR ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone, as well as current use of such agents.
- Received an investigational drug or device within 30 days (or 5 half-lives, whichever is longer) of dosing.
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- Previously assigned to treatment during this study (except those who did not take study medication).
- Screening QT interval corrected for heart rate by Fridericia's formula (QTcF) > 450 (males) or 470 (females) millisecond (msec) or an ECG that is not suitable for QT measurements (e.g., poorly defined termination of T-wave in the investigator's opinion).
- Type I or Type II diabetes.
- History of severe renal or hepatic impairment, in the opinion of the investigator or the sponsor-designated medical monitor.
- History of excessive bleeding, blood thinners within 6 months, antibiotics or infection within 3 months (CSF cohort only), lumbar spine abnormality, history of elevated intracranial pressure, normal pressure hydrocephalus or other neurological conditions considered clinically significant by the investigator.
- Human immunodeficiency virus infection, hepatitis, or other ongoing infectious disease that the investigator considers clinically significant.
- Current evidence of dysplasia or history of malignancy (including lymphoma and leukemia) in the last 5 years, with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- History of seizures.
- History of gastrointestinal disease or surgery (except simple appendectomy or hernia repair), which can influence the absorption of the study drug.
- History of any type of psychosis (including but not limited to bipolar disease or schizophrenia).
- Medical history or conditions that, in the opinion of the investigator, would preclude safe study participation, or interfere with study procedures/assessments.
- Evidence of an infection at the time of clinic admission, in the opinion of the investigator.
- Poor venous access.
- Use of prescription or over-the-counter medications, including herbal therapies within 7 days prior to dosing, or during the treatment and follow-up periods. Use of St. John's wort within 14 days prior to dosing, or during the treatment and follow-up periods. Occasional aspirin may be used at the investigator's discretion.
- Unable to eat a standardized meal offered by the study center.
- Donated or had a loss of blood or plasma within 8 weeks prior to dosing.
- Grapefruit juice or Seville oranges within 14 days prior to dosing or during the dosing period.
- Heart rate ≤ 45 beats per minutes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Daily Oral NYX2925 in Healthy Volunteers
This is a first in human study of NYX-2925. It will evaluate single and multiple ascending doses of NYX-2925 in healthy volunteers.
Read the detailed description
This is a first in human study of NYX-2925. This is a randomized, double-blind, sponsor-open, placebo-controlled, single and multiple ascending dose, parallel safety, tolerability, and PK study of oral NYX-2925 in healthy volunteers. The single ascending dose phase will comprise up to five dose groups. There will be up to 3 dose groups in the multiple ascending dose phase. One open-label dose group will be repeated in the multiple ascending dose phase to collect cerebrospinal fluid (CSF) samples, in order to explore central nervous system penetration. One elderly cohort (single dose) will be completed after all single and multiple dose escalation groups have completed. One open-label dose group will be repeated in the single ascending dose phase to collect CSF samples, in order to establish a more complete cerebral spinal fluid pharmacokinetic profile.
The influence of food ("food effect") on the bioavailability and pharmacokinetics of NYX-2925 will be explored in one dose group in the single ascending dose phase.
A data review committee will review safety and tolerability (adverse events and other relevant data), plus preliminary pharmacokinetic data, prior to proceeding to the next higher dose group, cohort, and/or phase of the study, as well as administration of the fed dose in the food effect group.
Stopping rules for individual study participants and dose groups or cohorts are established in order to evaluate the dose escalation scheme, the need to stop or terminate dosing, or to establish the maximum tolerated dose. If a cohort is stopped due to safety or tolerability concerns, the previous cohort may be repeated to determine the highest tolerated dose.
- Conditions
- Healthy Volunteers
- Being tested
- NYX-2925
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NYX-2925Drug
NYX-2925 is a small molecule that acts as an N-methyl-D-aspartate receptor (NMDAR) functional glycine-site partial agonist.
| Study group | Role | What they receive |
|---|---|---|
| SAD Phase | Placebo comparator | Up to 36 subjects: 50 - 1200 mg NYX-2925, Up to 12 subjects: placebo
6 additional subjects will receive a fed dose of NYX-2925, 2 additional subjects will receive a fed dose of placebo (Food Effect Cohort)
6 additional subjects will receive 1 dose of 50 mg NYX-2925 followed by a lumbar puncture at 1 and 4 (3 subjects) or 2 and 8 (3 subjects) hours post dose Receives: Drug: NYX-2925 |
| MAD Phase | Placebo comparator | Up to 24 subjects : 150 - 600 mg NYX-2925 daily for 7 days, up to 6 subjects : placebo daily for 7 days
6 additional subjects will receive 300 mg NYX-2925 daily for 7 days and undergo lumbar puncture on Day 6 in order to have two CSF samples taken (CSF Cohort). Receives: Drug: NYX-2925 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: Subjects will be followed for up to 30 days post-dose
Secondary outcomes (9)
Cmax of NYX-2925
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Tmax of NYX-2925
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
AUC of NYX-2925
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Half-life of NYX-2925
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Clearance of NYX-2925
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Volume of distribution of NYX-2925
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Renal elimination of NYX-2925
Measured: 0-4, 4-8, 8-12, 12-16, and 16-24 hours post dose.
Food effect of NYX-2925 following consumption of a high-fat, high-caloric meal
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
CSF penetration of NYX-2925 in CSF cohort
Measured: 1, 2, 2.5, and 8 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 posted15 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptinyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Clinical Research LLC
- Responsible party
- Sponsor
- Investigators
- Carlos Sanabria, MD, Principal investigator, Spaulding Clinical Research LLCLaurel Sindelar, Study director, Aptinyx Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834741
- Sponsor's protocol ID
- NYX-2925-1001
- Status last verified
- Apr 2017
- First submitted
- 13 Jul 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Daily Oral NYX2925 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02834741
- Acronym / sponsor ID
- NYX-2925-1001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- AptinyxIndustry (pharma, biotech, devices)
- Collaborators
- Spaulding Clinical Research LLC
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Jul 2016 (estimated)
- 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 is a first in human study of NYX-2925. It will evaluate single and multiple ascending doses of NYX-2925 in healthy volunteers.
Detailed description
This is a first in human study of NYX-2925. This is a randomized, double-blind, sponsor-open, placebo-controlled, single and multiple ascending dose, parallel safety, tolerability, and PK study of oral NYX-2925 in healthy volunteers. The single ascending dose phase will comprise up to five dose groups. There will be up to 3 dose groups in the multiple ascending dose phase. One open-label dose group will be repeated in the multiple ascending dose phase to collect cerebrospinal fluid (CSF) samples, in order to explore central nervous system penetration. One elderly cohort (single dose) will be completed after all single and multiple dose escalation groups have completed. One open-label dose group will be repeated in the single ascending dose phase to collect CSF samples, in order to establish a more complete cerebral spinal fluid pharmacokinetic profile.
The influence of food ("food effect") on the bioavailability and pharmacokinetics of NYX-2925 will be explored in one dose group in the single ascending dose phase.
A data review committee will review safety and tolerability (adverse events and other relevant data), plus preliminary pharmacokinetic data, prior to proceeding to the next higher dose group, cohort, and/or phase of the study, as well as administration of the fed dose in the food effect group.
Stopping rules for individual study participants and dose groups or cohorts are established in order to evaluate the dose escalation scheme, the need to stop or terminate dosing, or to establish the maximum tolerated dose. If a cohort is stopped due to safety or tolerability concerns, the previous cohort may be repeated to determine the highest tolerated dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAD Phase | Placebo comparator | Drug: NYX-2925Up to 36 subjects: 50 - 1200 mg NYX-2925, Up to 12 subjects: placebo 6 additional subjects will receive a fed dose of NYX-2925, 2 additional subjects will receive a fed dose of placebo (Food Effect Cohort) 6 additional subjects will receive 1 dose of 50 mg NYX-2925 followed by a lumbar puncture at 1 and 4 (3 subjects) or 2 and 8 (3 subjects) hours post dose |
| MAD Phase | Placebo comparator | Drug: NYX-2925Up to 24 subjects : 150 - 600 mg NYX-2925 daily for 7 days, up to 6 subjects : placebo daily for 7 days 6 additional subjects will receive 300 mg NYX-2925 daily for 7 days and undergo lumbar puncture on Day 6 in order to have two CSF samples taken (CSF Cohort). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and female subjects.
- 18 to 55 years of age, inclusive, at the time of signing the informed consent form (ICF). 55 to 80 years of age for elderly cohort.
- Female subjects with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (e.g., oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study.
- Male subjects and their female sexual partner should use an acceptable method of birth control during the study. Male subjects must agree to use barrier contraception (condom with spermicide), and refrain from sperm donation, from the first dose of study drug until 90 days after the last dose of study drug.
- Clinical laboratory values within normal limits or deemed not clinically significant by the investigator and/or the sponsor.
Key exclusion criteria (24 listed)
- Clinically significant alcohol or other substance abuse within the last 24 months, in the opinion of the investigator; or, unable to abstain from alcoholic beverages during the course of the study.
- Positive screen for alcohol or drugs of abuse (with the exception of a positive result considered by the investigator to be directly attributable to prescription medication approved for subject use): including benzodiazepines, opiates, cocaine, cannabinoids, and amphetamines.
- History of smoking or tobacco use within 30 days of Screening.
- Women who are pregnant, breast feeding, or planning to become pregnant during the course of the study.
- History of allergy, sensitivity, or intolerance to NMDAR ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone, as well as current use of such agents.
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 |
|---|---|---|
| NYX-2925NYX-2925 is a small molecule that acts as an N-methyl-D-aspartate receptor (NMDAR) functional glycine-site partial agonist. | Drug | MAD Phase, SAD Phase |
Primary outcome
Number of subjects with adverse events
Time frame: Subjects will be followed for up to 30 days post-dose
9 secondary outcomes
Cmax of NYX-2925
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Tmax of NYX-2925
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
AUC of NYX-2925
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Half-life of NYX-2925
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Clearance of NYX-2925
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Volume of distribution of NYX-2925
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Renal elimination of NYX-2925
Time frame: 0-4, 4-8, 8-12, 12-16, and 16-24 hours post dose.
Food effect of NYX-2925 following consumption of a high-fat, high-caloric meal
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
CSF penetration of NYX-2925 in CSF cohort
Time frame: 1, 2, 2.5, and 8 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 5 Apr 2017.
- Individual participant dataSharing planned: Yes
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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.
Carlos Sanabria, MD principal investigator
Spaulding Clinical Research LLC
Laurel Sindelar study director
Aptinyx Inc.
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 NYX-2925 in people with Healthy Volunteers, run by Aptinyx 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 9 inclusion and 24 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 5 Apr 2017. 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?
Number of subjects with adverse events (time frame: Subjects will be followed for up to 30 days 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 5 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.