Phase 1 ADME and IVMT study of LX9211 (QSC200438)
Research type
Research Study
Full title
A Phase 1, Open-label, Nonrandomized, 2-part Study to Evaluate the Absorption, Metabolism, Excretion, Mass Balance, and Absolute Bioavailability of 14C-LX9211, Following Oral and Intravenous (IV) Administration in Healthy Male Subjects
IRAS ID
264624
Contact name
Ernest Wang
Contact email
Sponsor organisation
Lexicon Pharmaceuticals, Inc.
Eudract number
2019-001785-14
Duration of Study in the UK
0 years, 1 months, 29 days
Research summary
The Sponsor is developing the test medicine, LX9211, for the potential treatment of neuropathic pain. \n\nNeuropathic pain is a type of pain caused by damage or disease to part of the nervous system. Neuropathic pain may be associated with increased pain from a normally painful stimulus (hyperalgesia), pain from normally non-painful stimuli (allodynia) and spontaneous pain that arises without an obvious cause. \n\nThe study will try to identify the absolute bioavailability of LX9211 i.e. how much of the test medicine is taken up by the body when dosed once by mouth compared to when dosed once by injection directly into the vein. The study will also identify how the medicine is absorbed (taken up), distributed, metabolised (broken down) and eliminated (removed) by the body when dosed once by mouth.\n\nThe study will consist of 2 parts, involving 12 healthy male volunteers. \nIn Part 1, 6 volunteers will receive a single dose of 50 mg LX9211 oral solution following an approximate 8 hour fast. Approximately 10 hours after the oral dose, volunteers will receive an intravenous microdose of radiolabelled 14C-LX9211 as a 15 minute infusion. Blood samples will be collected for up to 168 hours after dosing for determination of the concentration of LX9211 in the circulation from the oral dose, in comparison to the amount of 14C-LX9211 from intravenous infusion. Volunteers will be discharged on Day 8 and attend return visits on Days 11, 14, 21 and 28 for additional samples.\n\nIn Part 2, 6 volunteers will receive a single dose of 50 mg 14C-LX9211 oral solution following an overnight fast of approximately 8 hours. Volunteers will be discharged by Day 26, if not earlier, and attend return visits on Day 28 for additional samples.\n\nAll volunteers will receive an end of study telephone call on Day 35 to ensure their continued wellbeing.
REC name
HSC REC B
REC reference
19/NI/0111
Date of REC Opinion
11 Jun 2019
REC opinion
Favourable Opinion