Clinical trial NCT03712163: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Emergo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of subjects with adverse events following single doses
timeFrame: Through Day 4
measure: Number of subjects with adverse events following multiple doses
timeFrame: Through Day 7
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) following single doses
timeFrame: Through Day 4
measure: Maximum plasma concentration (Cmax) following multiple doses
timeFrame: Through Day 7
measure: Time to maximum concentration (Tmax) following single doses
timeFrame: Through Day 4
measure: Time to maximum concentration (Tmax) following multiple doses
timeFrame: Through Day 7
measure: Area under the plasma concentration time curve (AUC) following single doses
timeFrame: Through Day 4
measure: Area under the plasma concentration time curve (AUC) following multiple doses
timeFrame: Through Day 7
measure: Elimination half-life (t1/2) following single doses
timeFrame: Through Day 4
measure: Elimination half-life (t1/2) following multiple doses
timeFrame: Through Day 7
measure: Apparent clearance (CL/F) following single doses
timeFrame: Through Day 4
measure: Apparent clearance (CL/F) following multiple doses
timeFrame: Through Day 7
measure: Apparent volume of distribution (Vz/F) following single doses
timeFrame: Through Day 4
measure: Apparent volume of distribution (Vz/F) following multiple doses
timeFrame: Through Day 7
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials
state: Texas
Study officials:
affiliation: Worldwide Clinical Trials
name: Cynthia Zamora, MD
role: PRINCIPAL_INVESTIGATOR
References: