- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03712163
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
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
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78217
- Worldwide Clinical Trials
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Norketotifen or Placebo (Cohort 1)
|
Single dose Norketotifen
Placebo
|
Experimental: Norketotifen or Placebo (Cohort 2)
|
Placebo
Single dose Norketotifen
|
Experimental: Norketotifen or Placebo (Cohort 3)
|
Placebo
Single dose Norketotifen
|
Experimental: Norketotifen or Placebo (Multiple Dose)
|
Placebo
Multiple dose Norketotifen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Through Day 4
|
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
|
Through Day 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum plasma concentration (Cmax) following single doses
Time Frame: Through Day 4
|
Through Day 4
|
Maximum plasma concentration (Cmax) following multiple doses
Time Frame: Through Day 7
|
Through Day 7
|
Time to maximum concentration (Tmax) following single doses
Time Frame: Through Day 4
|
Through Day 4
|
Time to maximum concentration (Tmax) following multiple doses
Time Frame: Through Day 7
|
Through Day 7
|
Area under the plasma concentration time curve (AUC) following single doses
Time Frame: Through Day 4
|
Through Day 4
|
Area under the plasma concentration time curve (AUC) following multiple doses
Time Frame: Through Day 7
|
Through Day 7
|
Elimination half-life (t1/2) following single doses
Time Frame: Through Day 4
|
Through Day 4
|
Elimination half-life (t1/2) following multiple doses
Time Frame: Through Day 7
|
Through Day 7
|
Apparent clearance (CL/F) following single doses
Time Frame: Through Day 4
|
Through Day 4
|
Apparent clearance (CL/F) following multiple doses
Time Frame: Through Day 7
|
Through Day 7
|
Apparent volume of distribution (Vz/F) following single doses
Time Frame: Through Day 4
|
Through Day 4
|
Apparent volume of distribution (Vz/F) following multiple doses
Time Frame: Through Day 7
|
Through Day 7
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cynthia Zamora, MD, Worldwide Clinical Trials
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NKT-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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