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

Emergo Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo Oral Capsule; Drug: Norketotifen Oral Capsule (Cohort 1); Drug: Norketotifen Oral Capsule (Multiple Dose Cohort); Drug: Norketotifen Oral Capsule (Cohort 2); Drug: Norketotifen Oral Capsule (Cohort 3)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03712163

NKT-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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74 participants in 4 patient groups

Norketotifen or Placebo (Cohort 1)

Experimental group

Treatment:

Drug: Placebo Oral Capsule

Drug: Norketotifen Oral Capsule (Cohort 1)

Norketotifen or Placebo (Cohort 2)

Experimental group

Treatment:

Drug: Norketotifen Oral Capsule (Cohort 2)

Drug: Placebo Oral Capsule

Norketotifen or Placebo (Cohort 3)

Experimental group

Treatment:

Drug: Norketotifen Oral Capsule (Cohort 3)

Drug: Placebo Oral Capsule

Norketotifen or Placebo (Multiple Dose)

Experimental group

Treatment:

Drug: Norketotifen Oral Capsule (Multiple Dose Cohort)

Drug: Placebo Oral Capsule