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

Sponsor

Emergo Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03712163

Collaborator

(none)

Enrollment

Location

Arms

4.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: Norketotifen Oral Capsule (Cohort 1) Drug: Norketotifen Oral Capsule (Cohort 2) Drug: Norketotifen Oral Capsule (Cohort 3) Drug: Norketotifen Oral Capsule (Multiple Dose Cohort) Drug: Placebo Oral Capsule	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 15, 2018

Actual Primary Completion Date :

Feb 18, 2019

Actual Study Completion Date :

Mar 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Norketotifen or Placebo (Cohort 1)	Drug: Norketotifen Oral Capsule (Cohort 1) Single dose Norketotifen Drug: Placebo Oral Capsule Placebo
Experimental: Norketotifen or Placebo (Cohort 2)	Drug: Norketotifen Oral Capsule (Cohort 2) Single dose Norketotifen Drug: Placebo Oral Capsule Placebo
Experimental: Norketotifen or Placebo (Cohort 3)	Drug: Norketotifen Oral Capsule (Cohort 3) Single dose Norketotifen Drug: Placebo Oral Capsule Placebo
Experimental: Norketotifen or Placebo (Multiple Dose)	Drug: Norketotifen Oral Capsule (Multiple Dose Cohort) Multiple dose Norketotifen Drug: Placebo Oral Capsule Placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Maximum plasma concentration (Cmax) following single doses [Through Day 4]
Maximum plasma concentration (Cmax) following multiple doses [Through Day 7]
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]
Elimination half-life (t1/2) following multiple doses [Through Day 7]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Worldwide Clinical Trials	San Antonio	Texas	United States	78217

Sponsors and Collaborators

Emergo Therapeutics, Inc.

Investigators

Principal Investigator: Cynthia Zamora, MD, Worldwide Clinical Trials

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emergo Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT03712163

Other Study ID Numbers:

NKT-101

First Posted:

Oct 19, 2018

Last Update Posted:

Mar 21, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ketotifen

Study Results

No Results Posted as of Mar 21, 2019