Safety, Tolerability, and Pharmacokinetics of Modified and Immediate Release Anatabine Citrate Formulations
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|ClinicalTrials.gov Identifier: NCT02432313|
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : November 1, 2015
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.
Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and provides samples for PK analysis.
|Condition or disease||Intervention/treatment||Phase|
|Pharmacokinetics of Anatabine||Drug: Modified Release Formulation x (MRx)||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Modified Release Formulation x (MRx)
Various formulations of Modified Release anatabine citrate tablets
Drug: Modified Release Formulation x (MRx)
Subject receives 1 dose of a MRx and is followed. 7-day washout before dosing with another formulation
- PK measures of blood anatabine [ Time Frame: 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 ]
- reported adverse events or serious adverse events [ Time Frame: immediately post-dose to 5-days post-dose ]
- measures of pro-inflammatory mediators from stimulated peripheral blood mono-nuclear cells [ Time Frame: pre-dose to 12 hours post-dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432313
|Nottingham, United Kingdom, NG11 6JS|
|Principal Investigator:||Sharan Sidhu, MBChB, MRCS||Quotient Clinical|