Pharmacokinetics and Metabolism of 14 Carbon [14C]-GSK3640254
Status:
Completed
Trial end date:
2020-11-23
Target enrollment:
Participant gender:
Summary
This is an open-label, single-center, single group, non-randomized, two-period, single
sequence, mass balance study which will enroll 6 healthy male participants. This study will
assess the pharmacokinetics, balance/excretion, and metabolism of GSK3640254 in humans using
[14C]-radiolabeled drug substance administered as an intravenous (IV) infusion and via the
oral route. The study will also provide an assessment of GSK3640254 absorption, metabolism
and excretion following administration of a [14C]-radiolabeled oral suspension. Each
participant will be involved in the study for up to 10 weeks which will include a screening
period, two treatment periods (treatment Periods 1 and 2) separated by a washout of at least
13 days between oral doses, and a follow-up visit 7-14 days after the last assessment in
treatment Period 2.