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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
8
Dose level for inhalation
Dose level
Dry powder inhaler for mosliciguat
Pharmaron
Baltimore, Maryland, United States
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
Time frame: Baseline, Day 7
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
Urine and fecal recovery of total \[14C\] radioactivity, \[14C\]-mosliciguat
Time frame: Baseline, Day 28
Maximum observed concentration (Cmax)
Time frame: Baseline, Day 7
Evaluate the incidence of Treatment-Emergent Adverse Events (safety and tolerability of mosliciguat)
Incidence, nature, and severity of participant TEAEs, SAEs, and AEs
Time frame: Baseline, Day 44
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