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
Not Applicable
Not yet recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Drug: TPIP F2Drug: TPIP F3
- Registration Number
- NCT07102316
- Lead Sponsor
- Insmed Incorporated
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TPIP Dose A TPIP F2 Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period. TPIP Dose A TPIP F3 Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period. TPIP Dose B TPIP F2 Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period. TPIP Dose B TPIP F3 Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period. TPIP Dose C TPIP F2 Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period. TPIP Dose C TPIP F3 Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of Treprostinil (TRE) Pre-dose and post-dose at multiple timepoints up to Day 10 Area Under Plasma Concentration-Time Curve From 0 to Last Time Point With Quantifiable Concentration (AUClast) of TRE Pre-dose and post-dose at multiple timepoints up to Day 10 Area Under Plasma Concentration-Time Curve From 0 to Infinity (AUCinf) of TRE Pre-dose and post-dose at multiple timepoints up to Day 10
- Secondary Outcome Measures
Name Time Method Time to Reach Maximum Observed Plasma Concentration (Tmax) of TRE Pre-dose and post-dose at multiple timepoints up to Day 10 Terminal Elimination Half-Life (t1/2) of TRE Pre-dose and post-dose at multiple timepoints up to Day 10 Apparent Clearance Following Inhalation Administration (CL/F) of TRE Pre-dose and post-dose at multiple timepoints up to Day 10 Apparent Volume of Distribution at Terminal Phase (Vz/F) of TRE Pre-dose and post-dose at multiple timepoints up to Day 10 Dose-Normalized Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf/D) of TRE Pre-dose and post-dose at multiple timepoints up to Day 10 Dose-Normalized Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable (AUClast/D) of TRE Pre-dose and post-dose at multiple timepoints up to Day 10 Dose-Normalized Cmax and Calculated as Cmax/Dose of TRE Pre-dose and post-dose at multiple timepoints up to Day 10 Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAEs) Up to Day 17