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NCT07185321
An Open-Label, Phase 1 Study to Investigate the Absolute Bioavailability and the Absorption, Metabolism, and Excretion of [14C]-Mosliciguat in Healthy, Adult Males
Phase 1 trial testing Mosliciguat in Healthy Volunteer in 8 participants. Participants enrolled and being followed up; not accepting new ones.
1 March 2026
Quick facts
| Lead sponsor | Pulmovant, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | other |
| Enrollment | 8 |
| Start date | 10 June 2025 |
| Primary completion | 1 March 2026 |
| Estimated completion | 1 May 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Mosliciguat — full drug profile →
- 14C mosliciguat — full drug profile →
- Dry Powder Inhaler
Conditions studied
- Healthy Volunteer — all drugs for Healthy Volunteer →
Sponsor
Pulmovant, Inc. — full company profile →
Who can join
Adults 18 to 50, male only, with Healthy Volunteer. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Time frame: Baseline, Day 7
Absolute bioavailability of inhaled mosliciguat -
Area under the concentration-time curve (AUC) for mosliciguat
Time frame: 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
Time frame: Baseline, Day 28
Urine and fecal recovery of total \[14C\] radioactivity, \[14C\]-mosliciguat -
Maximum observed concentration (Cmax)
Time frame: Baseline, Day 7
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07185321
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07185321 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pulmovant, Inc.
- Last refreshed: 17 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07185321.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing