Absorption, Metabolism, and Excretion Study of [14C]-TNP-2092
Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
This is an open-label, single dose, Phase 1 study conducted at a single study center in the
United States (USA). This study will evaluate the absorption, metabolism and elimination
(AME), mass balance, safety and tolerability of a single dose of intravenously administered
[14C]-TNP-2092.
Healthy men aged 18 to 55, will be screened, and subjects who meet all eligibility criteria
and provide written informed consent will be enrolled into the study within 28 days of
Screening.
Subjects will be admitted to the clinical unit on the day prior to dosing (Day -1). Subjects
will fast overnight and then given a standard breakfast 30 min prior to dosing.
Six subjects will be enrolled in the study and each will receive a single intravenous (IV)
dose of 300 mg/3 μCi [14C]-TNP-2092 administered over 60 minutes (±10 minutes).