Healthy Volunteers
Conditions
Keywords
Phase 1, Safety, Tolerability, Pharmacokinetics, Parkinson's Disease
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.
Interventions
DRUGNPT200-11
Single doses of NPT200-11capsules, orally administered
DRUGPlacebo
Single doses of microcrystalline cellulose capsules, orally administered
Sponsors
UCB S.A. - Pharma Sector
Neuropore Therapies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety, including adverse events, physical examinations, ECGs, clinical laboratory tests | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To possibly determine the maximally tolerated dose (MTD) of orally administered NPT200-11 in healthy subjects. | 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. |
Countries
United States
Outcome results
None listed