Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
NCT ID: NCT03712163
Last Updated: 2019-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
74 participants
INTERVENTIONAL
2018-10-15
2019-03-14
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Norketotifen or Placebo (Cohort 1)
Norketotifen Oral Capsule (Cohort 1)
Single dose Norketotifen
Placebo Oral Capsule
Placebo
Norketotifen or Placebo (Cohort 2)
Norketotifen Oral Capsule (Cohort 2)
Single dose Norketotifen
Placebo Oral Capsule
Placebo
Norketotifen or Placebo (Cohort 3)
Norketotifen Oral Capsule (Cohort 3)
Single dose Norketotifen
Placebo Oral Capsule
Placebo
Norketotifen or Placebo (Multiple Dose)
Norketotifen Oral Capsule (Multiple Dose Cohort)
Multiple dose Norketotifen
Placebo Oral Capsule
Placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Negative serum pregnancy test (females); females of childbearing potential and males must agree to use acceptable contraception
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Emergo Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cynthia Zamora, MD
Role: PRINCIPAL_INVESTIGATOR
Worldwide Clinical Trials
Locations
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Worldwide Clinical Trials
San Antonio, Texas, United States
Countries
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Other Identifiers
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NKT-101
Identifier Type: -
Identifier Source: org_study_id
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