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Oral Nafamostat in Healthy Volunteers (NAF-101)

NCT04406415 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-09-24

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled Multiple Ascending Dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of oral nafamostat solution administered t.i.d.. for up to 5 days in healthy volunteer adult subjects

Conditions

  • Pharmacokinetics

Interventions

DRUG

Nafamostat Mesilate

Oral nafamostat, 10, 50, 100, or 200 mg administered three times daily for up to 5 days

DRUG

Placebo

Oral placebo administered three times daily for up to 5 days

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Ensysce Biosciences

    lead INDUSTRY

Principal Investigators

  • William K Schmidt, PhD · Ensysce Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2020-11-11
Completion
2021-05-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04406415 on ClinicalTrials.gov