Trial | NCT03712163  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    74
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.
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 Started
Oct 15
2018
Primary Completion
Feb 18
2019
Study Completion
Mar 14
2019
Last Update
Mar 21
2019

Drug Norketotifen Oral Capsule (Cohort 1)

Single dose Norketotifen

Drug Norketotifen Oral Capsule (Cohort 2)

Single dose Norketotifen

Drug Norketotifen Oral Capsule (Cohort 3)

Single dose Norketotifen

Drug Norketotifen Oral Capsule (Multiple Dose Cohort)

Multiple dose Norketotifen

Drug Placebo Oral Capsule

Placebo

Norketotifen or Placebo (Cohort 1) Experimental

Norketotifen or Placebo (Cohort 2) Experimental

Norketotifen or Placebo (Cohort 3) Experimental

Norketotifen or Placebo (Multiple Dose) Experimental

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
No Results Posted