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Completed

NCT Number: NCT03712163

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

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Norketotifen Oral Capsule (Multiple Dose Cohort)

Drug

Multiple dose Norketotifen

Placebo oral capsule

Drug

Placebo

Primary outcomes

  1. Number of subjects with adverse events following single doses

    Time frame: Through Day 4

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

  2. Number of subjects with adverse events following multiple doses

    Time frame: Through Day 7

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

Secondary outcomes

  1. Maximum plasma concentration (Cmax) following single doses

    Time frame: Through Day 4

  2. Maximum plasma concentration (Cmax) following multiple doses

    Time frame: Through Day 7

  3. Time to maximum concentration (Tmax) following single doses

    Time frame: Through Day 4

  4. Time to maximum concentration (Tmax) following multiple doses

    Time frame: Through Day 7

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

    Time frame: Through Day 4

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

    Time frame: Through Day 7

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

    Time frame: Through Day 4

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

    Time frame: Through Day 7

  9. Apparent clearance (CL/F) following single doses

    Time frame: Through Day 4

  10. Apparent clearance (CL/F) following multiple doses

    Time frame: Through Day 7

  11. Apparent volume of distribution (Vz/F) following single doses

    Time frame: Through Day 4

  12. Apparent volume of distribution (Vz/F) following multiple doses

    Time frame: Through Day 7

Sponsors and collaborators

Lead sponsor

Emergo Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2018
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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