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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPIP Dose A | Experimental | 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. |
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| TPIP Dose B | Experimental | 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. |
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| TPIP Dose C | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPIP F2 | Drug | Inhalation using a capsule-based dry powder inhaler device. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria
Female participants who are pregnant, nursing, or planning to become pregnant during the study.
Participant has a positive serology test result for human immunodeficiency virus 1 or 2, hepatitis C virus antibodies, or hepatitis B surface antigen or hepatitis B core antibodies at screening. A positive result for hepatitis C virus antibodies will be allowed, if the participant has documented proof of prior, successful treatment.
History of malignancy within 5 years prior to screening, with exception of completely treated in situ carcinoma of the cervix, and completely treated non-metastatic squamous cell or basal cell carcinoma of the skin.
Use of drugs that inhibit or induce Cytochrome P2C8 (CYP2C8) within 3 weeks prior to first dose until follow-up visit.
Participant has received any study drug in another investigational study within 30 days of screening or less than 5 times the drug's half-life, whichever is longer.
QT interval corrected for heart rate using Fridericia's formula (QTcF) > 450 milliseconds (ms).
The participant had active liver disease or hepatic dysfunction at screening or admission, manifested as:
Participant has a platelet count less than lower limit of normal and/or a history of abnormal bleeding or bruising.
Participant has a history of alcohol or drug abuse within 3 months before screening or excessive alcohol consumption (i.e., > 21 units/week for males, > 14 units/week for females) (1 unit is equal to approximately 1/2 pint [200 milliliters (mL)] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
Note: Other protocol defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA001 | Salt Lake City | Utah | 84124 | United States |
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| TPIP F3 | Drug | Inhalation using a capsule-based dry powder inhaler device. |
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| 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 |