An ADME Study of [14C]LTG-001 in Healthy Subjects (QSC303399)
Research type
Research Study
Full title
An Open-Label, Single-Dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]LTG-001 in Healthy Male Subjects
IRAS ID
1012272
Contact name
Neil Singla
Contact email
Sponsor organisation
Latigo Biotherapeutics, Inc.
ISRCTN Number
ISRCTN16655785
Research summary
The Sponsor is developing a new test medicine, LTG-001, to treat acute and chronic forms of pain. Acute pain is caused by injury, surgery, trauma or painful medical procedures, is short in duration, and disappears when the cause is resolved. Chronic pain is a constant and reoccurring pain that persists 3 or more months. We feel pain when our body sends messages through nerves to the brain. The test medicine helps by blocking one of the pain pathways in the nerves, so the brain doesn’t get as many pain signals.
Currently available medicines for pain such as anti-inflammatory, anti-depressants, anti-epileptics and opioid drugs do not work for everyone and can have troublesome side effects. The development of new treatments that are effective in the management of acute and chronic pain are required to meet this unmet need.
In this study, we’ll give healthy volunteers a single dose of test medicine to find out how the body breaks down and gets rid of the test medicine. The test medicine will be ‘radiolabelled’ - it will contain a small amount of radioactivity (Carbon-14) - so that we can track it in the body. We also want to get more information on whether the test medicine causes any important side effects.
This study will take place at 1 site in Nottingham. We plan to enrol 8 healthy men aged 30-65 years.
Volunteers will receive a single dose of radiolabelled test medicine, as capsules by mouth. They’ll stay in the clinic for up to 21 nights and take up to 7 weeks to finish the study.
We’ll collect blood and urine samples to do safety tests. Over a period of at least 14 days, we’ll take many blood samples and volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.
REC name
Wales REC 2
REC reference
25/WA/0220
Date of REC Opinion
17 Sep 2025
REC opinion
Further Information Favourable Opinion