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
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2018
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2019
CompletedMarch 21, 2019
March 1, 2019
4 months
October 12, 2018
March 19, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of subjects with adverse events following single doses
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
Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination
Through Day 7
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (4)
Norketotifen or Placebo (Cohort 1)
EXPERIMENTALNorketotifen or Placebo (Cohort 2)
EXPERIMENTALNorketotifen or Placebo (Cohort 3)
EXPERIMENTALNorketotifen or Placebo (Multiple Dose)
EXPERIMENTALInterventions
Multiple dose Norketotifen
Placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Worldwide Clinical Trials
San Antonio, Texas, 78217, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Zamora, MD
Worldwide Clinical Trials
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2018
First Posted
October 19, 2018
Study Start
October 15, 2018
Primary Completion
February 18, 2019
Study Completion
March 14, 2019
Last Updated
March 21, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share