PK of USWM-1033 MR Formulations in Healthy Subjects (QCL118252)
Research type
Research Study
Full title
A Phase 1, Single-Site, Open-Label Study Designed to Evaluate the Pharmacokinetic Profile of USWM-1033 following Single-Dose Administration of Modified Release Prototype Formulations and an Immediate Release Reference Formulation in Healthy Subjects
IRAS ID
242025
Contact name
Philip Evans
Contact email
Sponsor organisation
US WorldMeds LLC
Eudract number
2018-000293-29
Duration of Study in the UK
0 years, 9 months, 24 days
Research summary
The Sponsor is developing a new formulation of the test medicine, code name USWM-1033, for the potential treatment of opioid withdrawal symptoms. Opioids are a class of drug that include the illegal drug heroin, but also legal pain relieving medicines such as oxycodone, codeine and morphine. Opioid pain relievers are generally safe when taken for a short time and as prescribed by a doctor, but because they produce euphoria in addition to pain relief, they can be misused (taken in a different way or in a larger quantity than prescribed, or taken without a doctor’s prescription). Regular use—even when prescribed by a doctor—can lead to dependence. Opioid dependence is a serious global problem estimated to affect up to 36 million people worldwide.\n\nThe aim of this study is to develop a new formulation (recipe) of USWM-1033 that is longer lasting in the body and may reduce maximum levels of USWM-1033 found in the blood, therefore reducing side-effects related to this medication. A longer lasting formulation would be beneficial as this would enable a reduced dosing frequency ie “pill burden” to patients, which may in turn lead to improved treatment compliance.\n\nThe study will consist of up to 6 dosing periods, involving 20 healthy males and females. Volunteers will receive a single dose of USWM-1033 at each Period following an overnight fast, or after a high-fat breakfast, if selected. Volunteers will be admitted to the clinical unit on Day -1 and be discharged on either Day 3 (and attend a return visit on Day 4) or Day 4 of each period. There will be a minimum break of 4 days following dosing in Periods 1-3 and a minimum break of 14 days following dosing in Periods 3-6.
REC name
HSC REC A
REC reference
18/NI/0198
Date of REC Opinion
14 Nov 2018
REC opinion
Further Information Favourable Opinion