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Phase 1 Study of NPT200-11 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02606682
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : February 15, 2016
Sponsor:
Collaborator:
UCB S.A. - Pharma Sector
Information provided by (Responsible Party):
Neuropore Therapies Inc.

Tracking Information
First Submitted Date  ICMJE November 11, 2015
First Posted Date  ICMJE November 17, 2015
Last Update Posted Date February 15, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
Safety, including adverse events, physical examinations, ECGs, clinical laboratory tests [ Time Frame: Screening (28 days prior to dosing) through Day 7 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
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 ]
The number of participants with unacceptable toxicities at each dose level will determine the maximally tolerated dose.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study of NPT200-11 in Healthy Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Single Ascending Dose Trial of the Safety, Tolerability and Pharmacokinetics of NPT200-11 in Healthy Subjects
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: NPT200-11
    Single doses of NPT200-11capsules, orally administered
  • Drug: Placebo
    Single doses of microcrystalline cellulose capsules, orally administered
    Other Name: Microcrystalline cellulose capsules
Study Arms  ICMJE
  • Experimental: NPT200-11 - Cohort 1, Dose 1
    Single ascending dose of orally administered capsule(s) NPT200-11: 15 mg OR Single dose of orally administered placebo capsule(s) to match dose
    Interventions:
    • Drug: NPT200-11
    • Drug: Placebo
  • Experimental: NPT200-11 - Cohort 2, Dose 2
    Single ascending dose of orally administered capsule(s) NPT200-11: 30 mg OR Single dose of orally administered placebo capsule(s) to match dose
    Interventions:
    • Drug: NPT200-11
    • Drug: Placebo
  • Experimental: NPT200-11 - Cohort 3, Dose 3
    Single ascending dose of orally administered capsule(s) NPT200-11: 60 mg OR Single dose of orally administered placebo capsule(s) to match dose
    Interventions:
    • Drug: NPT200-11
    • Drug: Placebo
  • Experimental: NPT200-11 - Cohort 4, Dose 4
    Single ascending dose of orally administered capsule(s) NPT200-11: 120 mg OR Single dose of orally administered placebo capsule(s) to match dose
    Interventions:
    • Drug: NPT200-11
    • Drug: Placebo
  • Experimental: NPT200-11 - Cohort 5 ,Dose 5
    Single ascending dose of orally administered capsule(s) NPT200-11: 240 mg OR Single dose of orally administered placebo capsule(s) to match dose
    Interventions:
    • Drug: NPT200-11
    • Drug: Placebo
  • Experimental: NPT200-11 -Cohort 6, Dose 6
    Single ascending dose of orally administered capsule(s) NPT200-11: 360 mg OR Single dose of orally administered placebo capsule(s) to match dose
    Interventions:
    • Drug: NPT200-11
    • Drug: Placebo
  • Experimental: NPT200-11 - Cohort 7, Dose 7
    Single ascending dose of orally administered capsule(s) NPT200-11: 480 mg OR Single dose of orally administered placebo capsule(s) to match dose
    Interventions:
    • Drug: NPT200-11
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2016)
55
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2015)
56
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02606682
Other Study ID Numbers  ICMJE NPT200-11-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Neuropore Therapies Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Neuropore Therapies Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE UCB S.A. - Pharma Sector
Investigators  ICMJE
Principal Investigator: Danielle Armas, M.D. CPI Celerion
PRS Account Neuropore Therapies Inc.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP