clinical trial · NCT04392739
Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG
SIGA Technologies·phase4·completed·n = 34
SmallpoxTpoxx
brief summary
Safety and PK study in adults weighing more than 120 kg
started
Jul 19, 2019
primary completion
Dec 5, 2019
completion
Dec 5, 2019
last updated
Sep 19, 2024
detailed description
The primary objective of this study is to determine the pharmacokinetic (PK) profile of 600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing more than 120 kg to determine if a change in dosing regimen would be needed in these patients.
Secondary:
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg.
official title
A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of TPOXX In Adult Subjects Weighing More Than 120 KG
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol