Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects

Emergo Therapeutics, Inc.74 enrolled

Overview

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: 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Subjects

Interventions

Norketotifen Oral Capsule (Cohort 1)DRUG

Single dose Norketotifen

Norketotifen Oral Capsule (Cohort 2)DRUG

Single dose Norketotifen

Norketotifen Oral Capsule (Cohort 3)DRUG

Single dose Norketotifen

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Worldwide Clinical Trials

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Number of subjects with adverse events following single doses

Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination

Time frame: Through Day 4

Number of subjects with adverse events following multiple doses

Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination

Time frame: Through Day 7

Secondary Outcomes

Maximum plasma concentration (Cmax) following single doses

Time frame: Through Day 4

Maximum plasma concentration (Cmax) following multiple doses

Time frame: Through Day 7

Time to maximum concentration (Tmax) following single doses

Time frame: Through Day 4

Time to maximum concentration (Tmax) following multiple doses

Time frame: Through Day 7

Area under the plasma concentration time curve (AUC) following single doses

Time frame: Through Day 4

Area under the plasma concentration time curve (AUC) following multiple doses

Time frame: Through Day 7

Elimination half-life (t1/2) following single doses

Time frame: Through Day 4

Elimination half-life (t1/2) following multiple doses

Data from ClinicalTrials.gov

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