NCT07102316

A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants

A Phase 1, Open-Label, Randomized, 3-Group, Crossover Study to Assess the Relative Bioavailability After a Single Inhalation Administration of TPIP Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine the relative bioavailability of treprostinil (TRE) between the TPIP F2 and TPIP F3 at 3 capsule strengths, dose A, dose B, and dose C, in healthy participants following a single inhalation of TPIP dose.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TPIP F2	Inhalation using a capsule-based dry powder inhaler device.
DRUG	TPIP F3	Inhalation using a capsule-based dry powder inhaler device.

Timeline

• Start date: 2025-08-19
• Primary completion: 2025-10-25
• Completion: 2025-11-03
• First posted: 2025-08-03
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study