Healthy VolunteersPhase 1NCT03954600
A Study to Assess the Safety, Tolerability and PK of NPT520-34 in Healthy Subjects
A Phase 1 study testing NPT520-34 (125 mg) in people with Healthy Volunteers, run by Neuropore Therapies Inc. at 1 site in United States.
Trial summary
To evaluate the PK, safety and tolerability of orally administered NPT520-34 in healthy subjects at single and multiple doses that may be therapeutically relevant. 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?
- NPT520-34 (125 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2019to 9 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
- informed of, and willing and able to comply with, all of the protocol requirements and the investigational nature of the study, and have signed an informed consent form in accordance with institutional and regulatory guidelines;
- male or female adults between 18 and 55 years of age, inclusive;
- female subjects must be of non-childbearing potential (i.e. post-menopausal for at least 2 years) or surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation) or nonsurgically sterile (hysteroscopic sterilization, i.e. Essure);
- male subjects must be willing to use an adequate barrier method of contraception for the duration of the study and for 90 days after dosing and no sperm donations for the duration of the study and for 90 days after dosing. Male subjects who are surgically sterile (16 weeks post-surgery, or documented proof of Post-Vasectomy Semen Analysis (PVSA) with negative sperm results) need not employ a method of contraception;
- non-smokers for at least six months;
- BMI = 18.0 - 32.0 kg/m2 inclusive;
- in good health, in the judgment of the Investigator, as determined by: 7a. medical history indicative of no serious or severe chronic conditions requiring frequent medical intervention or continual pharmacologic management, and no medical or social conditions that would potentially interfere with the subject's ability to comply with the study visit schedule or the study assessments; 7b. no clinically significant abnormalities in body temperature, heart rate, respiratory rate, blood pressure; 7c. no clinically significant abnormalities in the 12-lead electrocardiogram (ECG); 7d. no clinically significant abnormalities in clinical chemistry (ALT, AST, total bilirubin must be at or below the upper limit of normal and eGFR must be ≥ 90 mL/min), hematology (hemoglobin ≥ 11.5 g/dL for females and ≥ 13 g/dL for males), coagulation and urinalysis; lab tests may be repeated, if necessary (details are provided in the attached flow chart of study assessments).
- negative results on the following screening laboratory tests: urine drug screen, urine alcohol screen, serum pregnancy test, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody.
Who cannot join
- females of child bearing potential
- history of a significant medical condition, including cholecystectomy or clinically significant GI tract resection, that may interfere with absorption, distribution or elimination of NPT520-34, or with the clinical and laboratory safety assessments in this study;
- history of pre-existing thyroid abnormalities, such as hyper or hypothyroidism;
- history of lactose intolerance;
- history of drug hypersensitivity and disorders affecting respiratory function (e.g., COPD, asthma) and cardiac disorders predisposing to cardiac adverse events
- history of or current alcohol abuse and/or other drug addiction < 2 years prior to screening, or a positive urine drug or alcohol screen (e.g., amphetamines, barbiturates, benzodiazepines, opiates, cannabinoids, alcohol and cocaine);
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- positive for HBVsAg, HCV Ab, HIV Ab;
- 12 lead ECG showing the following: having a corrected QTc interval > 450 msec or <340 msec (Fridericia's correction);
- sustained supine systolic blood pressure > 140 or < 90 mm Hg or supine diastolic blood pressure > 90 or < 50 mm Hg at Screening or Day -1. The average of the 2 assessments of BP taken at each visit will be used to exclude a subject;
- resting pulse rate at screening of > 100 or < 45.
- donated or lost > 500 mL of blood < 56 days prior to enrollment into this study;
- plasma donation within 7 days prior to enrollment into this study;
- active infection or febrile illness < 14 days prior to the first dose of study medication;
- use of prescription (including hormone replacement therapy) or over-the-counter medications or herbal supplements ≤ 14 days prior to dosing and until completion of follow-up visit on Day 7 for the SAD subjects and Day 21 for the MAD subjects;
- excessive regular caffeine intake (>250 mg of caffeine per day);
- have participated in other clinical studies of a new chemical entity within 30 days prior to admission to the CRU.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Single and Multiple Ascending Dose Trial of the Safety, Tolerability and Pharmacokinetics of NPT520-34 in Healthy Subjects
To evaluate the PK, safety and tolerability of orally administered NPT520-34 in healthy subjects at single and multiple doses that may be therapeutically relevant.
- Conditions
- Healthy Volunteers
- Being tested
- NPT520-34 (125 mg), Placebos (125 mg)
- Keywords
- Phase 1, Safety, Tolerability, Pharmacokinetics, Parkinson's Disease, Amyotrophic Lateral Sclerosis
- Medical subject headings
- Parkinson Disease, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPT520-34 (125 mg)Drug
NPT520-34, 125 mg oral capsules (size 1)
Placebos (125 mg)Drug
Placebo, 125 mg oral capsules
| Study group | Role | What they receive |
|---|---|---|
| NPT520-34 - SAD Cohort 1, Dose 1 (Unfed) | Other | Single ascending dose of orally administered capsule(s) NPT520-34: 125 mg OR Single dose of orally administered placebo capsule(s) to match dose. Unfed. Receives: Drug: NPT520-34 (125 mg); Drug: Placebos (125 mg) |
| NPT520-34 - SAD Cohort 1, Dose 1 (Fed) | Other | Single ascending dose of orally administered capsule(s) NPT520-34: 125 mg OR Single dose of orally administered placebo capsule(s) to match dose. Fed. Receives: Drug: NPT520-34 (125 mg); Drug: Placebos (125 mg) |
| NPT520-34 - SAD Cohort 2, Dose 2 | Other | Single ascending dose of orally administered capsule(s) NPT520-34: 250 mg OR Single dose of orally administered placebo capsule(s) to match dose. Receives: Drug: NPT520-34 (125 mg); Drug: Placebos (125 mg) |
| NPT520-34 - SAD Cohort 3, Dose 3 | Other | Single ascending dose of orally administered capsule(s) NPT520-34: 500 mg OR Single dose of orally administered placebo capsule(s) to match dose. Receives: Drug: NPT520-34 (125 mg); Drug: Placebos (125 mg) |
| NPT520-34 - SAD Cohort 4, Dose 4 | Other | Single ascending dose of orally administered capsule(s) NPT520-34: 1000 mg OR Single dose of orally administered placebo capsule(s) to match dose. Receives: Drug: NPT520-34 (125 mg); Drug: Placebos (125 mg) |
| NPT520-34 - MAD Cohort 1, Dose 1 | Other | Multiple ascending dose of orally administered capsule(s) NPT520-34: TBD mg OR Single dose of orally administered placebo capsule(s) to match dose. Receives: Drug: NPT520-34 (125 mg); Drug: Placebos (125 mg) |
| NPT520-34 - MAD Cohort 2, Dose 2 | Other | Multiple ascending dose of orally administered capsule(s) NPT520-34: TBD mg OR Single dose of orally administered placebo capsule(s) to match dose. Receives: Drug: NPT520-34 (125 mg); Drug: Placebos (125 mg) |
| NPT520-34 - MAD Cohort 3, Dose 3 | Other | Multiple ascending dose of orally administered capsule(s) NPT520-34: TBD mg OR Single dose of orally administered placebo capsule(s) to match dose. Receives: Drug: NPT520-34 (125 mg); Drug: Placebos (125 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerability of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
- Incidence of clinically significant treatment-emergent changes in the following clinical measures: 1) physical examination, 2) suicidal ideation, 3) vital signs 4) continuous telemetry for 1 hour prior to dosing and for 2 hours post-dose, 5) continuous telemetry for 1 hour prior to dosing and for 2 hours post-dose.
- Incidence in clinical significant treatment-emergent changes in the following laboratory measures: 1) hematology, 2) clinical chemistry, 3) FSH (post-menopausal women only), 4) coagulation, 5) urinalysis
- Incidence of treatment-emergent adverse events
- Incidence of treatment-emergent serious adverse events
Measured: Baseline, Day 1, 2 3, 5 and 7
Maximum observed plasma concentration of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Noncompartmental calculation of maximum observed plasma concentration (Cmax);
Measured: Day 1, 2, 3, 5, 7
Time to maximum plasma concentration of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Noncompartmental calculation of time to maximum plasma concentration (Tmax);
Measured: Day 1, 2, 3, 5, 7
Area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable plasma concentration of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Noncompartmental calculation of area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable plasma concentration [AUCt];
Measured: Day 1, 2, 3, 5, 7
Area under the plasma concentration-time curve extrapolated to infinity of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Noncompartmental calculation of area under the plasma concentration-time curve extrapolated to infinity (AUCinf) after dosing
Measured: Day 1, 2, 3, 5, 7
Apparent oral clearance of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Noncompartmental calculation of apparent oral clearance (CL/F)
Measured: Day 1, 2, 3, 5, 7
Apparent oral volume of distribution during the terminal phase of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Noncompartmental calculation of apparent oral volume of distribution during the terminal phase (Vz/F)
Measured: Day 1, 2, 3, 5, 7
Mean residence time of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Noncompartmental calculation of mean residence time (MRT)
Measured: Day 1, 2, 3, 5, 7
Terminal elimination half-life of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Noncompartmental calculation of terminal elimination half-life (T½);
Measured: Day 1, 2, 3, 5, 7
Safety/Tolerability as measures of hematology, clinical chemistry, FSH, coagulation and urinalysis of multiple ascending doses (250 mg and 500 mg)
- Incidence in clinical significant treatment-emergent changes in hematology
- Incidence in clinical significant treatment-emergent changes in clinical chemistry
- Incidence in clinical significant treatment-emergent changes in FSH (post-menopausal women only)
- Incidence in clinical significant treatment-emergent changes in coagulation
- Incidence in clinical significant treatment-emergent changes in urinalysis
Measured: Baseline, Day 2, 4, 7, 11, 12, 13, 14, and 21
Safety/Tolerability as measures of vital signs and physical examination of multiple ascending doses (250 mg and 500 mg)
- Incidence of clinically significant treatment-emergent changes in vital signs
- Incidence of clinically significant treatment-emergent changes in physical examination
Measured: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, 16, 18 Day 21
Safety/Tolerability as measures of continuous telemetry of multiple ascending doses (250 mg and 500 mg)
- Incidence of clinically significant treatment-emergent changes in continuous telemetry
Measured: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, and 15
Safety/Tolerability as measures of suicidal ideation, 12-lead ECG, adverse events and serious adverse events of multiple ascending doses (250 mg and 500 mg)
- Incidence in clinical significant treatment-emergent changes in suicidal ideation
- Incidence in clinical significant treatment-emergent changes in 12-lead ECG
- Incidence of treatment-emergent adverse events
- Incidence of treatment-emergent serious adverse events
Measured: Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18 Day 21
Safety/Tolerability as measure of continuous ECG of Multiple Ascending Doses (250 mg and 500 mg)
- Incidence in clinical significant treatment-emergent changes in continuous ECG telemetry
Measured: Baseline, Day 1, 7, and 14
Maximum observed plasma concentration (Cmax) after dosing on Day 1 of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of maximum observed plasma concentration (Cmax) after dosing on Day 1
Measured: Baseline, Day 1 and 2
Maximum observed concentration at steady-state after dosing on Day 14 of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of maximum observed concentration at steady-state after dosing on Day 14
Measured: Day 14
Concentration observed at the end of the dosing interval of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of concentration observed at the end of the dosing interval (Ctrough)
Measured: Day 14, 16, 18
Time to max. plasma concentration after dosing on Day 1 of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of time to max. plasma concentration after dosing on Day 1
Measured: Day 1
Time to reach Cmax,ss of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of time to reach Cmax,ss
Measured: Day 14, 16, 18 and 21
Area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable plasma concentration of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable plasma concentration (AUCt)
Measured: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, 16, 18 and 21
Area under the plasma concentration-time curve extrapolated to infinity after dosing of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of area under the plasma concentration-time curve extrapolated to infinity after dosing (AUCinf)
Measured: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, 16, 18 and 21
Area under the concentration time curve from 0-24 hours after dosing on Day 1 of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of the area under the concentration time curve from 0-24 hours after dosing on Day 1 (AUC0-24)
Measured: Day 1
The area under the concentration time curve during a dosing interval (tau) at steady state after dosing on Day 14 of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of the area under the concentration time curve during a dosing interval (tau) at steady state after dosing on Day 14 (AUCtau)
Measured: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, 16, 18 and 21
Apparent oral clearance of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of apparent oral clearance (CL/F)
Measured: Day 1
Apparent total plasma clearance after oral administration, calculated as Dose/AUCtau after dosing on Day 14 of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of apparent total plasma clearance after oral (extravascular) administration (CL,ss/F), calculated as Dose/AUCtau after dosing on Day 14
Measured: Day 14
Apparent oral volume of distribution during the terminal phase of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of apparent oral volume of distribution during the terminal phase (Vz/F)
Measured: Day 14, 16, 18 and 21
Mean residence time of Multiple Ascending Doses (250 mg, 500 mg)
Noncompartmental calculation of mean residence time (MRT)
Measured: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, 16, 18 and 21
Terminal elimination half-life of Multiple Ascending Doses (250 mg, 500 mg)
Terminal elimination half-life
Measured: Day 14, 16, 18 and 21
Secondary outcomes (2)
Maximum Tolerated Dose of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
- 2/6 subjects assigned to NPT520-34 have SAEs or Grade ≥3 lab abnormalities, considered related to study drug B) 1/6 subjects assigned to NPT520-34 has liver function tests, which: 1) ALT or AST>3x ULN or bilirubin >1.5x ULN and related to study drug C) 1/6 subjects assigned to NPT520-34 have liver function tests, which: 1) ALT or AST>3x ULN or bilirubin>1.5x ULN and related to study drug D) 1/ 6 subjects assigned to NPT520-34 have kidney function tests, which: 1) eGFR<60 mL/min and relationship to study drug is considered related, 2) serum creatinine>2x above baseline and relationship to study drug is considered related E) 2/ 6 subjects assigned to NPT520-34 have kidney function tests, which: 1) eGFR<60 mL/min and related to study drug, 2) serum creatinine > 2x above baseline and related to study drug F) Any subject experiences a SAE related to study drug G) Further dose escalation poses inappropriate safety risk according to Sponsor/Investigator
Measured: Day 1, 2, 3, 5, Day 7
Maximum Tolerated Dose of Multiple Ascending Doses (250 mg and 500 mg)
- 2/6 subjects assigned to NPT520-34 have SAEs or Grade ≥3 lab abnormalities, considered related to study drug B) 1/6 subjects assigned to NPT520-34 has liver function tests, which: 1) ALT or AST>3x ULN or bilirubin >1.5x ULN and related to study drug C) 1/6 subjects assigned to NPT520-34 have liver function tests, which: 1) ALT or AST>3x ULN or bilirubin>1.5x ULN and related to study drug D) 1/ 6 subjects assigned to NPT520-34 have kidney function tests, which: 1) eGFR<60 mL/min and relationship to study drug is considered related, 2) serum creatinine>2x above baseline and relationship to study drug is considered related E) 2/ 6 subjects assigned to NPT520-34 have kidney function tests, which: 1) eGFR<60 mL/min and related to study drug, 2) serum creatinine > 2x above baseline and related to study drug F) Any subject experiences a SAE related to study drug G) Further dose escalation poses inappropriate safety risk according to Sponsor/Investigator
Measured: Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18 Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start5 May 2019
- Primary completion2 Oct 2019
- Study completion9 Oct 2019
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuropore Therapies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Danielle Armas, M.D., Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954600
- Sponsor's protocol ID
- NPT520-34-001
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Single and Multiple Ascending Dose Trial of the Safety, Tolerability and Pharmacokinetics of NPT520-34 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03954600
- Acronym / sponsor ID
- NPT520-34-001
- Conditions
- Healthy Volunteers
- Keywords
- Phase 1, Safety, Tolerability, Pharmacokinetics, Parkinson's Disease, Amyotrophic Lateral Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Neuropore Therapies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 5 May 2019 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 17 May 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.
To evaluate the PK, safety and tolerability of orally administered NPT520-34 in healthy subjects at single and multiple doses that may be therapeutically relevant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| NPT520-34 - SAD Cohort 1, Dose 1 (Unfed) | Other | Drug: NPT520-34 (125 mg), Drug: Placebos (125 mg)Single ascending dose of orally administered capsule(s) NPT520-34: 125 mg OR Single dose of orally administered placebo capsule(s) to match dose. Unfed. |
| NPT520-34 - SAD Cohort 1, Dose 1 (Fed) | Other | Drug: NPT520-34 (125 mg), Drug: Placebos (125 mg)Single ascending dose of orally administered capsule(s) NPT520-34: 125 mg OR Single dose of orally administered placebo capsule(s) to match dose. Fed. |
| NPT520-34 - SAD Cohort 2, Dose 2 | Other | Drug: NPT520-34 (125 mg), Drug: Placebos (125 mg)Single ascending dose of orally administered capsule(s) NPT520-34: 250 mg OR Single dose of orally administered placebo capsule(s) to match dose. |
| NPT520-34 - SAD Cohort 3, Dose 3 | Other | Drug: NPT520-34 (125 mg), Drug: Placebos (125 mg)Single ascending dose of orally administered capsule(s) NPT520-34: 500 mg OR Single dose of orally administered placebo capsule(s) to match dose. |
| NPT520-34 - SAD Cohort 4, Dose 4 | Other | Drug: NPT520-34 (125 mg), Drug: Placebos (125 mg)Single ascending dose of orally administered capsule(s) NPT520-34: 1000 mg OR Single dose of orally administered placebo capsule(s) to match dose. |
| NPT520-34 - MAD Cohort 1, Dose 1 | Other | Drug: NPT520-34 (125 mg), Drug: Placebos (125 mg)Multiple ascending dose of orally administered capsule(s) NPT520-34: TBD mg OR Single dose of orally administered placebo capsule(s) to match dose. |
| NPT520-34 - MAD Cohort 2, Dose 2 | Other | Drug: NPT520-34 (125 mg), Drug: Placebos (125 mg)Multiple ascending dose of orally administered capsule(s) NPT520-34: TBD mg OR Single dose of orally administered placebo capsule(s) to match dose. |
| NPT520-34 - MAD Cohort 3, Dose 3 | Other | Drug: NPT520-34 (125 mg), Drug: Placebos (125 mg)Multiple ascending dose of orally administered capsule(s) NPT520-34: TBD mg OR Single dose of orally administered placebo capsule(s) to match dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- informed of, and willing and able to comply with, all of the protocol requirements and the investigational nature of the study, and have signed an informed consent form in accordance with institutional and regulatory guidelines;
- male or female adults between 18 and 55 years of age, inclusive;
- female subjects must be of non-childbearing potential (i.e. post-menopausal for at least 2 years) or surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation) or nonsurgically sterile (hysteroscopic sterilization, i.e. Essure);
- male subjects must be willing to use an adequate barrier method of contraception for the duration of the study and for 90 days after dosing and no sperm donations for the duration of the study and for 90 days after dosing. Male subjects who are surgically sterile (16 weeks post-surgery, or documented proof of Post-Vasectomy Semen Analysis (PVSA) with negative sperm results) need not employ a method of contraception;
- non-smokers for at least six months;
Key exclusion criteria (16 listed)
- females of child bearing potential
- history of a significant medical condition, including cholecystectomy or clinically significant GI tract resection, that may interfere with absorption, distribution or elimination of NPT520-34, or with the clinical and laboratory safety assessments in this study;
- history of pre-existing thyroid abnormalities, such as hyper or hypothyroidism;
- history of lactose intolerance;
- history of drug hypersensitivity and disorders affecting respiratory function (e.g., COPD, asthma) and cardiac disorders predisposing to cardiac adverse events
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 |
|---|---|---|
| NPT520-34 (125 mg)NPT520-34, 125 mg oral capsules (size 1) | Drug | NPT520-34 - MAD Cohort 1, Dose 1, NPT520-34 - MAD Cohort 2, Dose 2, NPT520-34 - MAD Cohort 3, Dose 3, NPT520-34 - SAD Cohort 1, Dose 1 (Fed), NPT520-34 - SAD Cohort 1, Dose 1 (Unfed), NPT520-34 - SAD Cohort 2, Dose 2, NPT520-34 - SAD Cohort 3, Dose 3, NPT520-34 - SAD Cohort 4, Dose 4 |
| Placebos (125 mg)Placebo, 125 mg oral capsules | Drug | NPT520-34 - MAD Cohort 1, Dose 1, NPT520-34 - MAD Cohort 2, Dose 2, NPT520-34 - MAD Cohort 3, Dose 3, NPT520-34 - SAD Cohort 1, Dose 1 (Fed), NPT520-34 - SAD Cohort 1, Dose 1 (Unfed), NPT520-34 - SAD Cohort 2, Dose 2, NPT520-34 - SAD Cohort 3, Dose 3, NPT520-34 - SAD Cohort 4, Dose 4 |
Primary outcome
Safety/Tolerability of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Time frame: Baseline, Day 1, 2 3, 5 and 7
A) Incidence of clinically significant treatment-emergent changes in the following clinical measures: 1) physical examination, 2) suicidal ideation, 3) vital signs 4) continuous telemetry for 1 hour prior to dosing and for 2 hours post-dose, 5) continuous telemetry for 1 hour prior to dosing and for 2 hours post-dose. B) Incidence in clinical significant treatment-emergent changes in the following laboratory measures: 1) hematology, 2) clinical chemistry, 3) FSH (post-menopausal women only), 4) coagulation, 5) urinalysis C) Incidence of treatment-emergent adverse events D) Incidence of treatment-emergent serious adverse events
Maximum observed plasma concentration of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Time frame: Day 1, 2, 3, 5, 7
Noncompartmental calculation of maximum observed plasma concentration (Cmax);
Time to maximum plasma concentration of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Time frame: Day 1, 2, 3, 5, 7
Noncompartmental calculation of time to maximum plasma concentration (Tmax);
Area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable plasma concentration of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Time frame: Day 1, 2, 3, 5, 7
Noncompartmental calculation of area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable plasma concentration [AUCt];
Area under the plasma concentration-time curve extrapolated to infinity of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Time frame: Day 1, 2, 3, 5, 7
Noncompartmental calculation of area under the plasma concentration-time curve extrapolated to infinity (AUCinf) after dosing
Apparent oral clearance of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Time frame: Day 1, 2, 3, 5, 7
Noncompartmental calculation of apparent oral clearance (CL/F)
Apparent oral volume of distribution during the terminal phase of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Time frame: Day 1, 2, 3, 5, 7
Noncompartmental calculation of apparent oral volume of distribution during the terminal phase (Vz/F)
Mean residence time of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Time frame: Day 1, 2, 3, 5, 7
Noncompartmental calculation of mean residence time (MRT)
Terminal elimination half-life of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Time frame: Day 1, 2, 3, 5, 7
Noncompartmental calculation of terminal elimination half-life (T½);
Safety/Tolerability as measures of hematology, clinical chemistry, FSH, coagulation and urinalysis of multiple ascending doses (250 mg and 500 mg)
Time frame: Baseline, Day 2, 4, 7, 11, 12, 13, 14, and 21
A) Incidence in clinical significant treatment-emergent changes in hematology B) Incidence in clinical significant treatment-emergent changes in clinical chemistry C) Incidence in clinical significant treatment-emergent changes in FSH (post-menopausal women only) D) Incidence in clinical significant treatment-emergent changes in coagulation E) Incidence in clinical significant treatment-emergent changes in urinalysis
Safety/Tolerability as measures of vital signs and physical examination of multiple ascending doses (250 mg and 500 mg)
Time frame: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, 16, 18 Day 21
A) Incidence of clinically significant treatment-emergent changes in vital signs B) Incidence of clinically significant treatment-emergent changes in physical examination
Safety/Tolerability as measures of continuous telemetry of multiple ascending doses (250 mg and 500 mg)
Time frame: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, and 15
A) Incidence of clinically significant treatment-emergent changes in continuous telemetry
Safety/Tolerability as measures of suicidal ideation, 12-lead ECG, adverse events and serious adverse events of multiple ascending doses (250 mg and 500 mg)
Time frame: Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18 Day 21
A) Incidence in clinical significant treatment-emergent changes in suicidal ideation B) Incidence in clinical significant treatment-emergent changes in 12-lead ECG C) Incidence of treatment-emergent adverse events D) Incidence of treatment-emergent serious adverse events
Safety/Tolerability as measure of continuous ECG of Multiple Ascending Doses (250 mg and 500 mg)
Time frame: Baseline, Day 1, 7, and 14
A) Incidence in clinical significant treatment-emergent changes in continuous ECG telemetry
Maximum observed plasma concentration (Cmax) after dosing on Day 1 of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Baseline, Day 1 and 2
Noncompartmental calculation of maximum observed plasma concentration (Cmax) after dosing on Day 1
Maximum observed concentration at steady-state after dosing on Day 14 of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Day 14
Noncompartmental calculation of maximum observed concentration at steady-state after dosing on Day 14
Concentration observed at the end of the dosing interval of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Day 14, 16, 18
Noncompartmental calculation of concentration observed at the end of the dosing interval (Ctrough)
Time to max. plasma concentration after dosing on Day 1 of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Day 1
Noncompartmental calculation of time to max. plasma concentration after dosing on Day 1
Time to reach Cmax,ss of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Day 14, 16, 18 and 21
Noncompartmental calculation of time to reach Cmax,ss
Area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable plasma concentration of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, 16, 18 and 21
Noncompartmental calculation of area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable plasma concentration (AUCt)
Area under the plasma concentration-time curve extrapolated to infinity after dosing of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, 16, 18 and 21
Noncompartmental calculation of area under the plasma concentration-time curve extrapolated to infinity after dosing (AUCinf)
Area under the concentration time curve from 0-24 hours after dosing on Day 1 of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Day 1
Noncompartmental calculation of the area under the concentration time curve from 0-24 hours after dosing on Day 1 (AUC0-24)
The area under the concentration time curve during a dosing interval (tau) at steady state after dosing on Day 14 of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, 16, 18 and 21
Noncompartmental calculation of the area under the concentration time curve during a dosing interval (tau) at steady state after dosing on Day 14 (AUCtau)
Apparent oral clearance of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Day 1
Noncompartmental calculation of apparent oral clearance (CL/F)
Apparent total plasma clearance after oral administration, calculated as Dose/AUCtau after dosing on Day 14 of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Day 14
Noncompartmental calculation of apparent total plasma clearance after oral (extravascular) administration (CL,ss/F), calculated as Dose/AUCtau after dosing on Day 14
Apparent oral volume of distribution during the terminal phase of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Day 14, 16, 18 and 21
Noncompartmental calculation of apparent oral volume of distribution during the terminal phase (Vz/F)
Mean residence time of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Baseline, Day 1, 2, 7, 8, 9, 10, 11, 14, 16, 18 and 21
Noncompartmental calculation of mean residence time (MRT)
Terminal elimination half-life of Multiple Ascending Doses (250 mg, 500 mg)
Time frame: Day 14, 16, 18 and 21
Terminal elimination half-life
2 secondary outcomes
Maximum Tolerated Dose of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg)
Time frame: Day 1, 2, 3, 5, Day 7
Maximum Tolerated Dose of Multiple Ascending Doses (250 mg and 500 mg)
Time frame: Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18 Day 21
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 Jan 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
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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.
Danielle Armas, M.D. principal investigator
Celerion
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 NPT520-34 (125 mg) in people with Healthy Volunteers, run by Neuropore Therapies 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 8 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 13 Jan 2020. 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?
Safety/Tolerability of Single Ascending Doses (125 mg, 250 mg, 500 mg and 1000 mg) (time frame: Baseline, Day 1, 2 3, 5 and 7). The study lists 28 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 13 Jan 2020.