Healthy Subjects
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGNorketotifen Oral Capsule (Cohort 1)
Single dose Norketotifen
DRUGNorketotifen Oral Capsule (Cohort 2)
Single dose Norketotifen
DRUGNorketotifen Oral Capsule (Cohort 3)
Single dose Norketotifen
DRUGNorketotifen Oral Capsule (Multiple Dose Cohort)
Multiple dose Norketotifen
DRUGPlacebo Oral Capsule
Placebo
Sponsors
Emergo Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events following single doses | Through Day 4 | Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination |
| Number of subjects with adverse events following multiple doses | Through Day 7 | Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum concentration (Tmax) following single doses | Through Day 4 |
| Time to maximum concentration (Tmax) following multiple doses | Through Day 7 |
| Area under the plasma concentration time curve (AUC) following single doses | Through Day 4 |
| Area under the plasma concentration time curve (AUC) following multiple doses | Through Day 7 |
| Elimination half-life (t1/2) following single doses | Through Day 4 |
| Maximum plasma concentration (Cmax) following single doses | Through Day 4 |
| Apparent clearance (CL/F) following single doses | Through Day 4 |
| Apparent clearance (CL/F) following multiple doses | Through Day 7 |
| Apparent volume of distribution (Vz/F) following single doses | Through Day 4 |
| Apparent volume of distribution (Vz/F) following multiple doses | Through Day 7 |
| Elimination half-life (t1/2) following multiple doses | Through Day 7 |
| Maximum plasma concentration (Cmax) following multiple doses | Through Day 7 |
Countries
United States
Outcome results
None listed