EpilepsyPhase 1NCT05503511
Safety and Pharmacokinetic Study of NPT 2042 Soft-gelatin Capsules Administered Orally to Healthy Adult Subjects
A Phase 1 study of Epilepsy and Alzheimer Disease, run by NeuroPro Therapeutics, Inc. at 1 site in United States.
Trial summary
Study NPT 2042 CL 101 is a first in human (FIH) study to evaluate the safety and pharmacokinetics (PK) of single and repeated ascending doses of NPT 2042 in healthy adult male and female subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Alzheimer Disease, Epilepsy Intractable
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2022to 30 Mar 2023
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive
- A minimum body weight of 50 kg for males and 45 kg for females
- All females must have a negative serum pregnancy test at Screening and a negative serum pregnancy test upon admission to the clinical research center.
- Females must be of nonchild-bearing potential defined as permanently sterile (i.e., due to hysterectomy) or postmenopausal (defined as more than one year since last menstrual period).
- Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subjects) plus an additional barrier method (female partner) of contraception for the duration of the study and for at least 90 days after dosing; subjects must also agree to refrain from sperm donation for at least 90 days after their last dose of IP.
- Able to swallow capsules.
Who cannot join
- Presence of active or recurring clinically-significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
- Presence of an active malignancy or a malignancy of any type within the past five years, other than squamous cell or basal cell carcinoma of the skin.
- Personal or family history of long QT syndrome.
- History or evidence of adverse symptoms associated with phlebotomy or blood donation (e.g., prolonged bleeding after injury or shaving, frequent epistaxis or gingival bleeding, bruises easily).
- History of clinically significant vertigo, dizziness or orthostatic hypotension or any vasovagal syncope or recurrent presyncope in connection with orthostatic challenge.
- Reported use of or inability to refrain from or anticipated use of during the study
Show all 16Show fewer
- any prescription drug within 14 days prior to dosing;
- any nonprescription drug, nutritional supplement, or vitamin within 7 days prior to dosing; NOTE: acetaminophen is allowed at a dose of ≤2000 mg/day
- any known enzyme-inducer or enzyme-inhibitor including St. John's Wort within 28 days prior to dosing, or
- reported chronic exposure to enzyme inducers such as paint solvents or pesticides within 30 days of dosing.
- Supine blood pressure (BP) less than 80/50 mmHg or greater than 140/90 mmHg.
- Supine heart rate <40 bpm and >90 bpm.
- History of drug abuse or current use of drugs of abuse or excessive ethanol intake
- Current Smoking, vaping, hookah, chewing tobacco, or history of smoking/vaping/chewing any substance
- Average consumption of ≥3 caffeine-containing beverages or xanthine-containing foods per day.
- Positive urine drug, alcohol, or cotinine result at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Placebo Controlled, Double-blind, Ascending Single-dose and Repeated-dose Trial to Determine the Safety and Pharmacokinetic Profile of NPT 2042 Soft-Gelatin Capsules Administered Orally to Healthy Adult Subjects
Study NPT 2042 CL 101 is a first in human (FIH) study to evaluate the safety and pharmacokinetics (PK) of single and repeated ascending doses of NPT 2042 in healthy adult male and female subjects.
Read the detailed description
The long-term goal of this program is to develop NPT 2042 an adjunct antiseizure treatment for patients with medically intractable epilepsy. Prior to evaluating efficacy in the intended patient population, safety and pharmacokinetics of NPT 2042 will be investigated.
- Conditions
- Epilepsy, Alzheimer Disease, Epilepsy Intractable
- Being tested
- NPT 2042 (bumetanide analog) or Matching Placebo
- Keywords
- CNS Disorder, Seizure Disorder
- Medical subject headings
- Epilepsy, Alzheimer Disease, Drug Resistant Epilepsy, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPT 2042 (bumetanide analog) or Matching PlaceboDrug
Soft gelatin capsules
| Study group | Role | What they receive |
|---|---|---|
| Part A; Cohort 1 | Experimental | QD dosing of 10mg (1 day) Receives: Drug: NPT 2042 (bumetanide analog) or Matching Placebo |
| Part A; Cohort 2 | Experimental | QD dosing of 50mg (1 day) Receives: Drug: NPT 2042 (bumetanide analog) or Matching Placebo |
| Part A; Cohort 3 | Experimental | QD dosing of 160mg (1 day) Receives: Drug: NPT 2042 (bumetanide analog) or Matching Placebo |
| Part B; Cohort 1 | Experimental | Every 12-hour dosing of 20mg (7 days) Receives: Drug: NPT 2042 (bumetanide analog) or Matching Placebo |
| Part B; Cohort 2 | Experimental | Every 12-hour dosing of 40mg (7 days) Receives: Drug: NPT 2042 (bumetanide analog) or Matching Placebo |
| Part B; Cohort 3 | Experimental | Every 12-hour dosing of 80mg (7 days) Receives: Drug: NPT 2042 (bumetanide analog) or Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Absolute values and change from baseline after a single dose or after 7 days of repeated dosing.
Measured: Up to 11 days
Number of participants with abnormal lab test results
Absolute values and change from baseline after a single dose or after 7 days of repeated dosing in clinical chemistry, hematology, and urinalysis.
Measured: Up to 11 days
Number of participants with abnormal vital signs
Absolute values and change from baseline after a single dose or after 7 days of repeated dosing in vital signs (oral body temperature, respiratory rate, blood pressure, and heart rate).
Measured: Up to 11 days
Number of participants with abnormal ECG
Absolute values and change from baseline after a single dose or after 7 days of ECG intervals.
Measured: Up to 7 days
Secondary outcomes (8)
Pharmacokinetic Cmax
Maximum (peak) observed concentration of NPT 2042.
Measured: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic Tmax
Time to maximum observed concentrations of NPT 2042.
Measured: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic half-life (t1/2)
Time to terminal elimination half-life concentrations of NPT 2042.
Measured: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic AUClast
Area under the concentration-time curve from zero to the last concentration quantifiable for NPT 2042.
Measured: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic AUCinf
Area under the plasma concentration-time curve from time zero extrapolated to infinity for NPT 2042.
Measured: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic CL/F
Apparent total plasma clearance after oral administration of NPT 2042.
Measured: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic VzF
Apparent volume of distribution during terminal elimination phase after oral administration of NPT 2042.
Measured: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Dose proportionality
Dose proportionality of NPT 2042 will be assessed using the power model.
Measured: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start20 Oct 2022
- Primary completion17 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroPro Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503511
- Sponsor's protocol ID
- NPT 2042 CL-101
- Status last verified
- Apr 2023
- First submitted
- 28 Jul 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Placebo Controlled, Double-blind, Ascending Single-dose and Repeated-dose Trial to Determine the Safety and Pharmacokinetic Profile of NPT 2042 Soft-Gelatin Capsules Administered Orally to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05503511
- Acronym / sponsor ID
- NPT 2042 CL-101
- Conditions
- Epilepsy, Alzheimer Disease, Epilepsy Intractable
- Keywords
- CNS Disorder, Seizure Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NeuroPro Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 16 Aug 2022 (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.
Study NPT 2042 CL 101 is a first in human (FIH) study to evaluate the safety and pharmacokinetics (PK) of single and repeated ascending doses of NPT 2042 in healthy adult male and female subjects.
Detailed description
The long-term goal of this program is to develop NPT 2042 an adjunct antiseizure treatment for patients with medically intractable epilepsy. Prior to evaluating efficacy in the intended patient population, safety and pharmacokinetics of NPT 2042 will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A; Cohort 1 | Experimental | Drug: NPT 2042 (bumetanide analog) or Matching PlaceboQD dosing of 10mg (1 day) |
| Part A; Cohort 2 | Experimental | Drug: NPT 2042 (bumetanide analog) or Matching PlaceboQD dosing of 50mg (1 day) |
| Part A; Cohort 3 | Experimental | Drug: NPT 2042 (bumetanide analog) or Matching PlaceboQD dosing of 160mg (1 day) |
| Part B; Cohort 1 | Experimental | Drug: NPT 2042 (bumetanide analog) or Matching PlaceboEvery 12-hour dosing of 20mg (7 days) |
| Part B; Cohort 2 | Experimental | Drug: NPT 2042 (bumetanide analog) or Matching PlaceboEvery 12-hour dosing of 40mg (7 days) |
| Part B; Cohort 3 | Experimental | Drug: NPT 2042 (bumetanide analog) or Matching PlaceboEvery 12-hour dosing of 80mg (7 days) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive
- A minimum body weight of 50 kg for males and 45 kg for females
- All females must have a negative serum pregnancy test at Screening and a negative serum pregnancy test upon admission to the clinical research center.
- Females must be of nonchild-bearing potential defined as permanently sterile (i.e., due to hysterectomy) or postmenopausal (defined as more than one year since last menstrual period).
- Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subjects) plus an additional barrier method (female partner) of contraception for the duration of the study and for at least 90 days after dosing; subjects must also agree to refrain from sperm donation for at least 90 days after their last dose of IP.
Key exclusion criteria (16 listed)
- Presence of active or recurring clinically-significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
- Presence of an active malignancy or a malignancy of any type within the past five years, other than squamous cell or basal cell carcinoma of the skin.
- Personal or family history of long QT syndrome.
- History or evidence of adverse symptoms associated with phlebotomy or blood donation (e.g., prolonged bleeding after injury or shaving, frequent epistaxis or gingival bleeding, bruises easily).
- History of clinically significant vertigo, dizziness or orthostatic hypotension or any vasovagal syncope or recurrent presyncope in connection with orthostatic challenge.
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 |
|---|---|---|
| NPT 2042 (bumetanide analog) or Matching PlaceboSoft gelatin capsules | Drug | Part A; Cohort 1, Part A; Cohort 2, Part A; Cohort 3, Part B; Cohort 1, Part B; Cohort 2, Part B; Cohort 3 |
Primary outcome
Number of participants with adverse events
Time frame: Up to 11 days
Absolute values and change from baseline after a single dose or after 7 days of repeated dosing.
Number of participants with abnormal lab test results
Time frame: Up to 11 days
Absolute values and change from baseline after a single dose or after 7 days of repeated dosing in clinical chemistry, hematology, and urinalysis.
Number of participants with abnormal vital signs
Time frame: Up to 11 days
Absolute values and change from baseline after a single dose or after 7 days of repeated dosing in vital signs (oral body temperature, respiratory rate, blood pressure, and heart rate).
Number of participants with abnormal ECG
Time frame: Up to 7 days
Absolute values and change from baseline after a single dose or after 7 days of ECG intervals.
8 secondary outcomes
Pharmacokinetic Cmax
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic Tmax
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic half-life (t1/2)
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic AUClast
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic AUCinf
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic CL/F
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic VzF
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Dose proportionality
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
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 Apr 2023.
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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 of Epilepsy and Alzheimer Disease, run by NeuroPro Therapeutics, 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 6 inclusion and 16 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 Apr 2023. 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. 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 participants with adverse events (time frame: Up to 11 days). The study lists 4 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 4 Apr 2023.