Tempe, Arizona 85283


Purpose:

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.


Criteria:

Inclusion Criteria: Subjects who meet all of the following inclusion criteria will be eligible to participate in this study: 1. 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; 2. male or female adults between 18 and 55 years of age, inclusive; 3. female subjects must be post-menopausal for at least 2 years or surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation); 4. 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; 5. non-smokers for at least six months; 6. BMI = 18 - 30 kg/m2, inclusive; 7. 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). 8. 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. Exclusion Criteria: 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; - 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.


Study is Available At:


Original ID:

NPT200-11-001


NCT ID:

NCT02606682


Secondary ID:


Study Acronym:


Brief Title:

Phase 1 Study of NPT200-11 in Healthy Subjects


Official Title:

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


Overall Status:

Recruiting


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Neuropore Therapies Inc.


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

7


Number of Groups:

0


Total Enrollment:

56


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Dennis Swearingen, M.D.
Principal Investigator
Celerion
Primary Contact:Doug Bonhaus, Ph.D.
858-273-1831
Doug.Bonhaus@neuropore.com
Backup Contact:Francisco M Lio, B.S.
858-273-1831
Francisco.Lio@neuropore.com

Study Dates

Start Date:July 2015
Completion Date:March 2016
Completion Type:Anticipated
Primary Completion Date:March 2016
Primary Completion Type:Anticipated
Verification Date:November 2015
Last Changed Date:November 16, 2015
First Received Date:November 11, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To possibly determine the maximally tolerated dose (MTD) of orally administered NPT200-11 in healthy subjects.
Time Frame:Screening (28 days prior to dosing) through Day 7 of MTD
Safety Issues:True
Description:The number of participants with unacceptable toxicities at each dose level will determine the maximally tolerated dose.
Outcome Type:Primary Outcome
Measure:Safety, including adverse events, physical examinations, ECGs, clinical laboratory tests
Time Frame:Screening (28 days prior to dosing) through Day 7
Safety Issues:True
Description: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

Study Interventions

Intervention Type:Drug
Name:NPT200-11
Description:Single doses of NPT200-11capsules, orally administered
Arm Name:NPT200-11 - Cohort 1, Dose 1
Intervention Type:Drug
Name:Placebo
Description:Single doses of microcrystalline cellulose capsules, orally administered
Arm Name:NPT200-11 - Cohort 1, Dose 1
Other Name:Microcrystalline cellulose capsules

Study Arms

Study Arm Type:Experimental
Arm Name:NPT200-11 - Cohort 1, Dose 1
Description:Single ascending dose of orally administered capsule(s) NPT200-11: 15 mg OR Single dose of orally administered placebo capsule(s) to match dose
Study Arm Type:Experimental
Arm Name:NPT200-11 - Cohort 2, Dose 2
Description:Single ascending dose of orally administered capsule(s) NPT200-11: 30 mg OR Single dose of orally administered placebo capsule(s) to match dose
Study Arm Type:Experimental
Arm Name:NPT200-11 - Cohort 3, Dose 3
Description:Single ascending dose of orally administered capsule(s) NPT200-11: 60 mg OR Single dose of orally administered placebo capsule(s) to match dose
Study Arm Type:Experimental
Arm Name:NPT200-11 - Cohort 4, Dose 4
Description:Single ascending dose of orally administered capsule(s) NPT200-11: 120 mg OR Single dose of orally administered placebo capsule(s) to match dose
Study Arm Type:Experimental
Arm Name:NPT200-11 - Cohort 5 ,Dose 5
Description:Single ascending dose of orally administered capsule(s) NPT200-11: 240 mg OR Single dose of orally administered placebo capsule(s) to match dose
Study Arm Type:Experimental
Arm Name:NPT200-11 -Cohort 6, Dose 6
Description:Single ascending dose of orally administered capsule(s) NPT200-11: 360 mg OR Single dose of orally administered placebo capsule(s) to match dose
Study Arm Type:Experimental
Arm Name:NPT200-11 - Cohort 7, Dose 7
Description:Single ascending dose of orally administered capsule(s) NPT200-11: 480 mg OR Single dose of orally administered placebo capsule(s) to match dose

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Neuropore Therapies Inc.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:UCB S.A. - Pharma Sector

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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