Phase 1 PK and safety study of low-dose Naltrexone (QCL117809)
Research type
Research Study
Full title
A Two Part, Sequential, Open Label Study Designed to Investigate the Pharmacokinetics, Safety and Tolerability of Single and Multiple Ascending Doses of Orally Administered Low-Dose Naltrexone in Healthy Subjects
IRAS ID
234803
Contact name
Francis Hood
Contact email
Sponsor organisation
LDN Pharma Ltd.
Eudract number
2017-003358-18
Duration of Study in the UK
0 years, 4 months, 14 days
Research summary
The Sponsor is developing a new study drug, low-dose naltrexone, for the potential treatment of diseases in which inflammation plays a role e.g. autoimmune diseases such as scleroderma. Autoimmune disease happen when the body attacks itself leading to damage. Scleroderma is where the immune system attacks the body which responds by making too much collagen. This causes the skin to become thick and tighten. In severe forms scars can form in internal organs. Naltrexone is currently marketed for the treatment of patients with opioid or alcohol dependence. Naltrexone blocks receptors in the brain and body to which opioids such as morphine bind. Opioid receptors are also present on immune system cells.\n\nThe study will try to identify the level of the study drug present in the blood following single and multiple doses of low-dose naltrexone. The safety and tolerability of low-dose naltrexone will also be investigated.\n\nThe study will consist of 2 parts involving healthy male and female subjects. In Part 1, up to 40 subjects will be enrolled and will attend the clinical unit on one occasion. Up to five treatment regimens (A-E) will be dosed, with Regimen E being an optional regimen, 8 subjects will be enrolled per regimen. Each subject will receive a single dose of low-dose naltrexone on Day 1 and will remain in the clinical unit until Day 3. Part 2 will enrol up to 24 subjects who will attend the clinical unit on one occasion. Three treatment regimens (F-H) will be involved, each regimen will enrol 8 subjects. Subjects will receive a once-daily dose of low-dose naltrexone for up to 7 days. Subjects will remain in the clinical unit until Day 9. There will be a follow-up phone call with each subject from Part 1 and 2 three to five days after the subjects last dose. \n\n
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0535
Date of REC Opinion
25 Oct 2017
REC opinion
Favourable Opinion