Healthy Volunteer
Conditions
Brief summary
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.
Interventions
DRUGMosliciguat
Dose level for inhalation
DRUG14C mosliciguat
Dose level
DEVICEDry Powder Inhaler
Dry powder inhaler for mosliciguat
Sponsors
Pulmovant, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants willing and able to provide informed consent. * Considered to be in good health by the Investigator, as determined by medical history, physical examination, vital sign measurements, 12 lead electrocardiogram (ECG), and laboratory test results.
Exclusion criteria
* History or presence of any condition (e.g., chronic diarrhea, urinary incontinence), or prior surgery (e.g., gastric bypass) that, in the opinion of the Investigator, poses a significant risk to participant safety and/or achievement of study objectives * History or presence of COPD, moderate or persistent asthma, other chronic lung disease, or chronic respiratory condition within the last 5 years * Acute or recent respiratory infection symptoms not resolved at least 3 days prior to Period 1 check-in.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Day 7 | Absolute bioavailability of inhaled mosliciguat |
| 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 | Baseline, Day 28 | Urine and fecal recovery of total \[14C\] radioactivity, \[14C\]-mosliciguat |
| Maximum observed concentration (Cmax) | Baseline, Day 7 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the incidence of Treatment-Emergent Adverse Events (safety and tolerability of mosliciguat) | Baseline, Day 44 | Incidence, nature, and severity of participant TEAEs, SAEs, and AEs |
Countries
United States
Outcome results
None listed