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

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ClinicalTrials.gov Identifier: NCT03712163
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Emergo Therapeutics, Inc.

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.


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Study Type : Interventional  (Clinical Trial)
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 : October 15, 2018
Actual Primary Completion Date : February 18, 2019
Actual Study Completion Date : March 14, 2019

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712163


Locations
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United States, Texas
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Emergo Therapeutics, Inc.
Investigators
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Principal Investigator: Cynthia Zamora, MD Worldwide Clinical Trials

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Responsible Party: Emergo Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03712163     History of Changes
Other Study ID Numbers: NKT-101
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ketotifen
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents