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

NCT03712163 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-03-21

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • Emergo Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Cynthia Zamora, MD · Worldwide Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2019-02-18
Completion
2019-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712163 on ClinicalTrials.gov