Safety, Tolerability, and Pharmacokinetics of Modified and Immediate Release Anatabine Citrate Formulations
|ClinicalTrials.gov Identifier: NCT02432313|
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : November 2, 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|
|Primary Completion Date :||October 2015|
|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 ]
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|