Oral Nafamostat in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pharmacokinetics
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Double-blind, placebo-controlled, Multiple Ascending Dose (MAD) study with 4 active drug cohortsMasking: Single (Participant)Masking Description: This is a double-blinded study. Subjects will not be informed of their treatment assignment (active or placebo); however, investigators and clinical site staff will have access to the randomization codes.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Subjects will undergo a medical screening (Days -1 to -10) and, if eligible, informed consent will be obtained prior to 6 days of confinement at the clinic site. Up to 20 subjects will be randomized. Subjects will be stratified to include an equal number of male and female subjects who will receive ...
Subjects will undergo a medical screening (Days -1 to -10) and, if eligible, informed consent will be obtained prior to 6 days of confinement at the clinic site. Up to 20 subjects will be randomized. Subjects will be stratified to include an equal number of male and female subjects who will receive active drug within each dose cohort, and an equal number of male and female subjects in the combined placebo group. Separate groups of volunteers will be used for each dose cohort. There will be 4 dose cohorts in this study with active drug doses of 10, 50, 100, and 200 mg nafamostat in succeeding cohorts. Each cohort of 5 subjects will enroll 2 male and 2 female to receive active drug and 1 subject (male or female) to receive placebo for a total of 20 subjects. The placebo subject from each cohort will be combined into a placebo cohort that will have 4 subjects to compare to 4 subjects in each of the active dose groups.
Tracking Information
- NCT #
- NCT04406415
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Study Director: William K Schmidt, PhD Ensysce Biosciences
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