NCT03712163

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Emergo Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Norketotifen Oral Capsule (Cohort 1)	Single dose Norketotifen
DRUG	Norketotifen Oral Capsule (Cohort 2)	Single dose Norketotifen
DRUG	Norketotifen Oral Capsule (Cohort 3)	Single dose Norketotifen
DRUG	Norketotifen Oral Capsule (Multiple Dose Cohort)	Multiple dose Norketotifen
DRUG	Placebo Oral Capsule	Placebo

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-02-18
• Completion: 2019-03-14
• First posted: 2018-10-19
• Last updated: 2019-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study