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This is a single-center, Phase 1, open-label, 3-period, fixed-sequence study to investigate the bioavailability, absorption, metabolism, excretion and the safety of mosliciguat administered to healthy male adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mosliciguat (RVT-2301) | Experimental | Mosliciguat administered daily via dry powder inhaler. |
|
| 14C mosliciguat | Experimental | Administered orally and via IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mosliciguat | Drug | Dose level for inhalation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the absolute bioavailability (ABA) of mosliciguat following administration of a single inhaled dose of mosliciguat followed by an IV microtracer dose of [14C]-mosliciguat in healthy adult males | Absolute bioavailability of inhaled mosliciguat | Baseline, Day 7 |
| Area under the concentration-time curve (AUC) for mosliciguat | Baseline, Day 7 | |
| Assess the mass balance (i.e., cumulative excretion in urine and feces compared to the administered amount of radioactive isotope) of [14C] following a single oral dose of mosliciguat solution | Urine and fecal recovery of total [14C] radioactivity, [14C]-mosliciguat | Baseline, Day 28 |
| Maximum observed concentration (Cmax) | Baseline, Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the incidence of Treatment-Emergent Adverse Events (safety and tolerability of mosliciguat) | Incidence, nature, and severity of participant TEAEs, SAEs, and AEs | Baseline, Day 44 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ubaldo Martin | Pulmovant, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D058995 | Dry Powder Inhalers |
| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| D004864 | Equipment and Supplies |
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| 14C mosliciguat |
| Drug |
Dose level |
|
| Dry Powder Inhaler | Device | Dry powder inhaler for mosliciguat |
|