*Open-Label, Bioavailability Study to Compare Liquid vs Solid IP2015
Research type
Research Study
Full title
An Open-Label, Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015 in Healthy Male Subjects (Study code: IP2015CS04)
IRAS ID
1006400
Contact name
Mikael Thomsen
Contact email
Sponsor organisation
Initiator Pharma
Eudract number
2022-002657-26
Clinicaltrials.gov Identifier
Research summary
Research Summary:
This a Phase I, open-label, 3-way crossover study to determine the bioavailability of two capsule formulations (immediate-release and extended-release) of IP2015 compared to liquid formulation of IP2015 in healthy male subjects. Currently, 200 million people worldwide suffer from neuropathic pain, also known as diabetic polyneuropathy. Inadequate response to drug treatments constitutes a substantial unmet need in patients with neuropathic pain, and currently, less than one-third of painful diabetic neuropathy patients derive sufficient pain relief with existing pharmacotherapies. This study is designed to support the development of the IP2015 capsule formulations which are being developed for the treatment of neuropathic pain. Single oral doses of 5 mg immediate-release IP2015 capsules and 5 mg extended-release IP2015 capsules will be compared with a single oral dose of 5mg liquid IP2015 to determine whether the bioavailability of IP2015 administered as a capsule, either immediate-release or extended-release, is equivalent to IP2015 administered as a liquid. The study participants for this study will include healthy male subjects aged between 18 and 55 years, with a body mass index (BMI) of 18 to 30 kg/m2 (inclusive). A single clinical research facility will be selected for this study. Each subject will take part in 3 Treatment Periods and will receive each treatment once only. There will be a minimum washout period of 7 days between each treatment administration. Subjects will attend a Follow-up visit 5 to 7 days after final dosing. The duration of participation for each subject is expected to last approximately 9 weeks.
Summary of Results:
An Open-Label Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015 in Healthy Male Subjects.
MAC Number: MAC156
Protocol Number: IP2015CS04The study was organised and funded by Initiator Pharma (the ‘Sponsor’) and was conducted by MAC Clinical Research in Teesside, United Kingdom, from January 2023 to March 2023.
Why was this study conducted?
The main aim of this study was to test two different solid capsule formulations of a drug called IP2015 (the ‘study drug’) against the liquid formulation to compare bioavailability (how the body absorbs and removes the drug).Who took part in the study?
Twelve healthy male subjects were randomly divided into one of 3 treatment sequences, where they were all administered 3 different formulations of IP2015 across 3 different treatment periods:Treatment Sequence Treatment Period 1 Treatment Period 2 Treatment Period 3
Treatment Sequence 1: Immediate-release capsule, Extended release capsule, Liquid
Treatment Sequence 2: Liquid, Immediate release capsule, Extended-release capsule
Treatment Sequence 3: Extended-release capsule, Liquid, Immediate-release capsuleWhat were the overall results of the study?
The study showed that both solid formulations of IP2015 (extended-release capsule and immediate-release capsule) were comparable to the liquid formulation in terms of absorption and removal of the drug from the body. This demonstrates that the solid dosing formulations have relevant bioavailability data to support future treatment settings in Phase II and Phase III trials.
Side effects are unwanted medical issues during the study that may or may not be related to the study drug. The reported side effects in this study were mild in severity and at most, were only considered to be potentially related to the treatment.How has this study helped patients and researchers?
This study has helped researchers to understand how the body absorbs and removes the drug when it is given in different formulations. This research helps future patients and families by helping us to understand more about the medicine being studied. Findings from this study will be used to inform further studies into IP2015 and its relationship to other treatments.Where can I find more information about this study?
To learn more about this study, visit: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5BfNaGAzEjHWwhIXBaJXq-2FWtMOT7_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKJ9d2ppnQUCiF2euaw0i7kvjfm7vXt5UhjUEFYEmoFSqd7gZ5jy3CuJ0-2FlnqP9jOfSrpD8n6H5s6hBMZ-2BrAhSx8OrUbE-2F-2F9JAADrOY2yfYWEqKksLIrgZlxlIeN2UEz7EY2AxLvylqz1f5gT3COs8zt3tUpM0OKsojt2NAzO8-2FxQ-3D-3D&data=05%7C01%7Cbrent.rec%40hra.nhs.uk%7C2a3bf3b10a434997fae408dbf19b1eeb%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638369420795239880%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=NYniPxcMHKNPBskFCge0Wj9EEsiPvMEXqCrw1MevJKI%3D&reserved=0This summary was completed on 20 November 2023. Newer information since this summary was written may now exist. This summary includes only results from one single study. Other studies may find different results.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0647
Date of REC Opinion
7 Nov 2022
REC opinion
Further Information Favourable Opinion