PK of Modified Release Anatabine Citrate Formulations (QCL117443)
Research type
Research Study
Full title
A Three Part Study with Two 6 Period Single Dose Parts (Part 1 and Part 2 - Optional) Followed by a One Period Multiple Dose Part (Part 3) to Evaluate Prototype Modified Release Matrix and Multi Particulate Formulations of Anatabine Citrate to Determine the Pharmacokinetics of a Selected Modified Release Formulation Prototype and to Evaluate Safety and Tolerability in Healthy Subjects
IRAS ID
169000
Contact name
Michael Mullan
Contact email
Sponsor organisation
Rock Creek Pharmaceuticals Ic.
Eudract number
2014-003742-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 20 days
Research summary
The Sponsor is developing the study drug, anatabine (formulated as anatabine citrate), for treatment of specific inflammatory and autoimmune conditions. Autoimmune disorders are illnesses where the body's own immune system attacks cells in the body, and inflammatory conditions cause redness, swelling and pain.
The study will consist of up to 3 parts. Part 1 of the study will use different recipes (formulations) to make anatabine tablets which are given to 14 healthy volunteers as a single dose. How the drug is taken up and broken down by the body will be assessed after the tablets are taken. If Part 1 is not successful in identifying a suitable formulation of the study drug, Part 2 of the study will take place, which will assess further formulations of the study drug in a further 14 healthy volunteers.
In Part 3 of the study, a particular recipe will be selected to be given to 9 healthy volunteers multiple times. All parts of the study will look at how safe the study drug is and how it is taken up and broken down by the body.REC name
HSC REC A
REC reference
14/NI/1150
Date of REC Opinion
18 Dec 2014
REC opinion
Favourable Opinion