Safety, Tolerability, and Pharmacokinetics of Modified and Immediate Release Anatabine Citrate Formulations

Study Overview
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Brief Summary
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Parts 1 and 2: Subjects take 1 dose of various formulations of the study product, and provide samples for pharmacokinetic (PK) analysis after each, with at least 7 days between doses. Part 3: Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and provides samples for PK analysis.

Detailed Description
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Parts 1 and 2: Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast overnight and receive the study product in the morning of Day 1 in a non-randomized manner. Subjects will remain onsite until 24 h post-dose and will return to the clinical unit at 36 and 48 h post-dose to provide a sample for PK analysis. There will be at least a 7-day washout between regimens. Subject will be telephoned 3-5 days after the final dose to ensure his/her ongoing well-being. Part 3: Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast overnight (for Day 1 and Day 7) and receive the study product or placebo on a once, twice, or three times a day regimen in a randomized, double-blind manner. Subjects will remain onsite until 24 h after the final dose (Day 7), leaving the clinic on the morning of Day 8 and returning at 36 and 48 h post last-dose to provide a sample for PK analysis. Subject will be telephoned 3-5 days after the final dose to ensure his/her ongoing well-being.

Official Title
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3-Part Study With 2 6-Period Single Dose Parts (Pt 1, Pt 2 Optional) Followed by a 1-Period Multiple Dose Part (Pt 3) to Evaluate Prototype Modified Release Matrix and Multi Particulate Formulations of Anatabine Citrate to Determine PK

Conditions
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Pharmacokinetics of Anatabine

Intervention / Treatment
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* Drug: Modified Release Formulation x (MRx)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: negative for urinary cotinine normal test values for liver function provide informed consent Exclusion Criteria: clinically significant abnormal biochemistry, hematology, or urinalysis, as judged by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Release Formulation x (MRx)<br>Various formulations of Modified Release anatabine citrate tablets | Drug: Modified Release Formulation x (MRx)<br>* Subject receives 1 dose of a MRx and is followed. 7-day washout before dosing with another formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK measures of blood anatabine |  | 0-2 hrs (every 15 min); 2-6 hrs (every 30 min); 6-12 hr (every 60 min); at 18, 24, 36, and 48 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reported adverse events or serious adverse events |  | immediately post-dose to 5-days post-dose |