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Healthy VolunteersPhase 1NCT02606682

Phase 1 Study of NPT200-11 in Healthy Subjects

A Phase 1 study testing NPT200-11 in people with Healthy Volunteers, run by Neuropore Therapies Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the safety, tolerability and blood levels of orally administered NPT200-11 in healthy subjects. In addition, the maximally tolerated dose will be determined. 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?
NPT200-11
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 siteUnited States
Study dates
Jul 2015to Feb 2016
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

  • Subjects who meet all of the following inclusion criteria will be eligible to participate in this study:
  • 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 post-menopausal for at least 2 years or surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation);
  • 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 need not employ a method of contraception;
  • non-smokers for at least six months;
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  • BMI = 18 - 30 kg/m2, inclusive;
  • in good health, in the judgment of the Principal Investigator, as determined by:
  • 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;
  • no clinically significant abnormalities in body temperature, heart rate, respiratory rate, blood pressure;
  • no clinically significant abnormalities in the 12-lead electrocardiogram (ECG);
  • 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 above 90 mL/min), hematology (hemoglobin ≥ 12.0 g/dL), 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

  • Subjects who meet any of the following exclusion criteria will NOT be eligible to participate in this study:
  • females of child bearing potential;
  • history of a significant medical condition that may interfere with absorption, distribution or elimination of NPT200-11, or with the clinical and laboratory safety assessments in this study;
  • 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);
  • positive for HBVsAg, HCV Ab, HIV Ab;
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  • 12 lead ECG showing the following: having a corrected QTc interval > 450 msec or <320 msec (Fridericia's correction);
  • sustained sitting systolic blood pressure > 140 or < 90 mm Hg or sitting diastolic blood pressure > 90 or < 50 mm Hg at Screening or Day -1 (sentinel pair) or Day 1 (remaining 6 subjects in the cohort), 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 or over-the-counter medications or herbal supplements ≤ 14 days prior to dosing and until completion of follow-up visit on Day 7;
  • 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.

United States1 site

  • Celerion, Inc

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Single Ascending Dose Trial of the Safety, Tolerability and Pharmacokinetics of NPT200-11 in Healthy Subjects

The purpose of this study is to determine the safety, tolerability and blood levels of orally administered NPT200-11 in healthy subjects. In addition, the maximally tolerated dose will be determined.

Being tested
NPT200-11, Placebo
Keywords
Phase 1, Safety, Tolerability, Pharmacokinetics, Parkinson's Disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NPT200-11Drug

    Single doses of NPT200-11capsules, orally administered

  • PlaceboDrug

    Also called Microcrystalline cellulose capsules

    Single doses of microcrystalline cellulose capsules, orally administered

Study groups in NCT02606682
Study groupRoleWhat they receive
NPT200-11 - Cohort 1, Dose 1ExperimentalSingle ascending dose of orally administered capsule(s) NPT200-11: 15 mg OR Single dose of orally administered placebo capsule(s) to match dose
Receives: Drug: NPT200-11; Drug: Placebo
NPT200-11 - Cohort 2, Dose 2ExperimentalSingle ascending dose of orally administered capsule(s) NPT200-11: 30 mg OR Single dose of orally administered placebo capsule(s) to match dose
Receives: Drug: NPT200-11; Drug: Placebo
NPT200-11 - Cohort 3, Dose 3ExperimentalSingle ascending dose of orally administered capsule(s) NPT200-11: 60 mg OR Single dose of orally administered placebo capsule(s) to match dose
Receives: Drug: NPT200-11; Drug: Placebo
NPT200-11 - Cohort 4, Dose 4ExperimentalSingle ascending dose of orally administered capsule(s) NPT200-11: 120 mg OR Single dose of orally administered placebo capsule(s) to match dose
Receives: Drug: NPT200-11; Drug: Placebo
NPT200-11 - Cohort 5 ,Dose 5ExperimentalSingle ascending dose of orally administered capsule(s) NPT200-11: 240 mg OR Single dose of orally administered placebo capsule(s) to match dose
Receives: Drug: NPT200-11; Drug: Placebo
NPT200-11 -Cohort 6, Dose 6ExperimentalSingle ascending dose of orally administered capsule(s) NPT200-11: 360 mg OR Single dose of orally administered placebo capsule(s) to match dose
Receives: Drug: NPT200-11; Drug: Placebo
NPT200-11 - Cohort 7, Dose 7ExperimentalSingle ascending dose of orally administered capsule(s) NPT200-11: 480 mg OR Single dose of orally administered placebo capsule(s) to match dose
Receives: Drug: NPT200-11; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety, including adverse events, physical examinations, ECGs, clinical laboratory tests

    Safety, as determined by the number of participants with adverse events related to treatment, the number of participants with clinically significant changes in blood pressure, heart rate and respiration, the number of participants with abnormal laboratory values, the number of participants with abnormal ECGs.

    Measured: Screening (28 days prior to dosing) through Day 7

Secondary outcomes (1)

  1. To possibly determine the maximally tolerated dose (MTD) of orally administered NPT200-11 in healthy subjects.

    The number of participants with unacceptable toxicities at each dose level will determine the maximally tolerated dose.

    Measured: Screening (28 days prior to dosing) through Day 7 of MTD

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

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
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02606682
Sponsor's protocol ID
NPT200-11-001
Status last verified
Nov 2015
First submitted
11 Nov 2015
Last updated
15 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NPT200-11 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 13 inclusion and 14 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 15 Feb 2016. 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, including adverse events, physical examinations, ECGs, clinical laboratory tests (time frame: Screening (28 days prior to dosing) through Day 7). 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 NCT02606682.

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 15 Feb 2016.

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