NCT04392739

Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG

A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of TPOXX In Adult Subjects Weighing More Than 120 KG

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: SIGA Technologies · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Safety and PK study in adults weighing more than 120 kg

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.

Conditions

• Smallpox

Interventions

Type	Name	Description
DRUG	Tpoxx	oral antiviral

Timeline

• Start date: 2019-07-19
• Primary completion: 2019-12-05
• Completion: 2019-12-05
• First posted: 2020-05-19
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study