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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712163
• Other study ID #: NKT-101
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2018
• Est. completion date: March 14, 2019

Study information

• Verified date: March 2019
• Source: Emergo Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 14, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Norketotifen Oral Capsule (Cohort 1)
Single dose Norketotifen
• Norketotifen Oral Capsule (Cohort 2)
Single dose Norketotifen
• Norketotifen Oral Capsule (Cohort 3)
Single dose Norketotifen
• Norketotifen Oral Capsule (Multiple Dose Cohort)
Multiple dose Norketotifen
• Placebo Oral Capsule
Placebo

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Emergo Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through Day 4
Primary	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	Through Day 7
Secondary	Maximum plasma concentration (Cmax) following single doses		Through Day 4
Secondary	Maximum plasma concentration (Cmax) following multiple doses		Through Day 7
Secondary	Time to maximum concentration (Tmax) following single doses		Through Day 4
Secondary	Time to maximum concentration (Tmax) following multiple doses		Through Day 7
Secondary	Area under the plasma concentration time curve (AUC) following single doses		Through Day 4
Secondary	Area under the plasma concentration time curve (AUC) following multiple doses		Through Day 7
Secondary	Elimination half-life (t1/2) following single doses		Through Day 4
Secondary	Elimination half-life (t1/2) following multiple doses		Through Day 7
Secondary	Apparent clearance (CL/F) following single doses		Through Day 4
Secondary	Apparent clearance (CL/F) following multiple doses		Through Day 7
Secondary	Apparent volume of distribution (Vz/F) following single doses		Through Day 4
Secondary	Apparent volume of distribution (Vz/F) following multiple doses		Through Day 7