Mass Balance Study of [14C]encaleret in Healthy Male Subjects (QSC205855)
Research type
Research Study
Full title
An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]encaleret in Healthy Male Subjects
IRAS ID
1006991
Contact name
Scott Adler
Contact email
Sponsor organisation
Calcilytix Therapeutics, Inc., a BridgeBio Company
ISRCTN Number
ISRCTN59912845
Research summary
Summary of Research
The Sponsor is developing the test medicine, encaleret, for the potential treatment of the rare genetic disorder autosomal dominant hypocalcaemia type 1 (ADH1) which occurs in around 1 in 70,000 people. ADH1 is caused by a genetic mutation, resulting in decreased release of parathyroid hormone from the parathyroid glands and decreased urine calcium reabsorption in the kidneys. This results in excessive calcium excretion in the urine, which can lead to kidney calcifications, impaired kidney function, and low calcium and magnesium blood levels, which has heart and nerve effects, such as heart rhythm abnormalities, seizures, and muscle spasms and cramps.
This single part healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this the test medicine is radiolabelled meaning that the test medicine has a radioactive component (carbon-14; also referred to as 14C) which helps us track where the test medicine is in the body. This study will also try to identify the safety and tolerability of the test medicine, as well as evaluate its taste.
This study will take place at one non-NHS site, enrolling up to 8 male volunteers aged between 40 and 65 years.
On Day 1, up to 8 volunteers will receive a single oral dose of the radiolabelled test medicine in the fasted state (on an empty stomach). Volunteer’s blood, urine and faeces will be taken throughout the study for analysis of the test medicine and for their safety. Volunteers will remain in the clinical unit until Day 8, however if required levels of radioactive recovery (amount of radioactive component [14C] retrieved in the urine and faeces) have not been met, they may be required to remain at the clinical unit until Day 12. If relevant criteria have not been met at this point, home collections of urine and/or faeces may be required.
Volunteers are expected to be involved in this study for approximately 6 weeks from screening to discharge.Summary of Results
As this is a Phase I study, no lay summary of results has been provided, for reasons of commercial confidentiality.REC name
Wales REC 2
REC reference
23/WA/0008
Date of REC Opinion
22 Mar 2023
REC opinion
Further Information Favourable Opinion