Mass Balance, PK and metabolism study of [14C]PCO371 (QSC202934)
Research type
Research Study
Full title
A Phase I, Single-Center, Open-Label Study Investigating the Excretion Balance, Pharmacokinetics (PK) and Metabolism of a Single Oral Dose of [14C]PCO371 and PK of an Intravenous (IV) Tracer of [14C]PCO371 in Healthy Male Subjects
IRAS ID
284549
Contact name
Somasekhara Menakuru
Contact email
Sponsor organisation
Chugai Pharmaceutical Co., Ltd.
Eudract number
2020-000291-38
Duration of Study in the UK
0 years, 1 months, 15 days
Research summary
Research Summary:
The Sponsor is developing the test medicine, PCO371, for the potential treatment of hypoparathyroidism. Hypoparathyroidism is a rare condition where the parathyroid glands (cells in the neck) don’t produce enough parathyroid hormone (PTH), a chemical that helps regulate levels of minerals in the blood.The study involves radiolabelling (labelling the test medicine with radioactive 14C) which is used to locate the test medicine within the body. The study will try to assess the rates and routes of elimination of radioactivity and how much radioactivity can be recovered from the urine and faeces (mass balance recovery). It will also try to determine how much of the test medicine enters the bloodstream over time (pharmacokinetics). The study will try to identify which metabolites (breakdown products) are generated along with measuring the amount of oral test medicine that enters the bloodstream relative to the intravenous (IV) dose (absolute oral bioavailability). The safety and tolerability will also be assessed.
The study will consist of two parts involving up to 12 healthy male volunteers, split into two groups. In Part 1, volunteers will receive a single oral dose of [14C]PCO371 as a solution to drink. Volunteers will enter the clinical unit on Day -1 and remain resident until Day 5 at the earliest or Day 17 at the latest, depending on the recovery of total radioactivity. In Part 2, volunteers will receive a single oral dose of PCO371 as two capsules followed by a single IV infusion of [14C]PCO371, two hours post-oral dose. Volunteers will enter the clinical unit on Day -1 and remain resident until Day 5.
In both parts, blood, urine and faecal samples will be collected whilst the volunteer is resident at the clinical unit. There will be a follow-up for both parts, 5 – 10 days after discharge.
Summary of Results:
No lay summary of results has been provided given that this is a Phase I clinical pharmacology study in healthy volunteers and for reasons of commercial sensitivity.REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/0999
Date of REC Opinion
14 Sep 2020
REC opinion
Favourable Opinion