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The primary purpose of this study is to determine the safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo | Experimental | Participants received a single dose of Tyvaso® on Day 1, then randomized to receive either a single dose of C16TR for inhalation (Dose A) or matching placebo on Day 2 in Cohort 1. |
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| Cohort 2: C16TR Dose B or Placebo | Experimental | Participants were randomized to receive a single dose of C16TR for inhalation (Dose B) or matching placebo on Day 1 in Cohort 2. |
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| Cohort 3: C16TR Dose C or Placebo | Experimental | Participants were randomized to receive a single dose of C16TR for inhalation (Dose C) or matching placebo on Day 1 in Cohort 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C16TR | Drug | Administered as inhalation using a Philips Micro device inhaler. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experienced an Adverse Event (AE) | Safety and tolerability of escalating doses of C16TR for inhalation in healthy participants. | Up to 32 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) of Treprostinil and C16TR Post C16TR for Inhalation Dose | At multiple timepoints post dose on Days 2 to 4 | |
| Cohort 1: AUC of Treprostinil Post Tyvaso® Dosing | Pharmacokinetics of treprostinil after Tyvaso® dosing in healthy participants will be assessed. |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA001 | Los Angeles | California | 91206 | United States |
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| ID | Term |
|---|---|
| C000624715 | hexadecyl-treprostinil |
| C427248 | treprostinil |
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| Placebo | Drug | Phosphate buffered saline (PBS) administered using Philips Micro device inhaler. |
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| Tyvaso® | Drug | Administered as inhalation. |
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| At multiple timepoints post dose on Days 1 and 2 for Cohort 1 |
| Mean Change From Baseline in Corrected QT Interval by Fridericia (QTcF) for C16TR | Baseline up to Day 4 (Cohort 1) and Day 3 (Cohorts 2, 3, 4, and 5) |