Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/23/2019 |
| Start Date: | October 15, 2018 |
| End Date: | March 14, 2019 |
A Double-Blind, Placebo-Controlled, 2-Part, Single Ascending Dose and Multiple Dose Cohort Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, 2-part,
single ascending dose and multiple dose cohort study of orally administered Norketotifen
(NKT) in healthy subjects.
single ascending dose and multiple dose cohort study of orally administered Norketotifen
(NKT) in healthy subjects.
Single Ascending Dose: Three single ascending dose cohorts are planned. A total of 10
subjects will be enrolled in each cohort and will be randomly assigned to receive a single
oral dose of NKT (n=8) or a matching placebo (n=2). A Safety Review Team (SRT) will review
all available safety data in a blinded manner following the completion of each cohort to
determine the next dose level to be evaluated in the next cohort.
Multiple Dose Cohort: A total of 10 subjects will be enrolled and will be randomly assigned
to receive multiple oral doses of NKT (n=8) or a matching placebo (n=2) once daily for an
adequate number of days to reach steady state (the number of days will be determined based on
the half-life of NKT in Part A). The dose of NKT to be evaluated will be determined by the
SRT.
subjects will be enrolled in each cohort and will be randomly assigned to receive a single
oral dose of NKT (n=8) or a matching placebo (n=2). A Safety Review Team (SRT) will review
all available safety data in a blinded manner following the completion of each cohort to
determine the next dose level to be evaluated in the next cohort.
Multiple Dose Cohort: A total of 10 subjects will be enrolled and will be randomly assigned
to receive multiple oral doses of NKT (n=8) or a matching placebo (n=2) once daily for an
adequate number of days to reach steady state (the number of days will be determined based on
the half-life of NKT in Part A). The dose of NKT to be evaluated will be determined by the
SRT.
Key Inclusion Criteria:
- Body mass index (BMI) of 18 to 30 kg/m^2
- Negative serum pregnancy test (females); females of childbearing potential and males
must agree to use acceptable contraception
Key Exclusion Criteria:
- Pregnant or lactating (females)
- Clinically significant past or current medical or surgical history
- Clinically significant illness or abnormality on physical examination, 12-lead ECG,
laboratory values
- Participation in an investigational drug or device study within 30 days prior to
Screening
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