A Phase 1 Study of Mosliciguat in Healthy, Adult Males
Not Applicable
Active, not recruiting
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT07185321
- Lead Sponsor
- Pulmovant, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Mosliciguat (RVT-2301) Mosliciguat Mosliciguat administered daily via dry powder inhaler. Mosliciguat (RVT-2301) Dry Powder Inhaler Mosliciguat administered daily via dry powder inhaler. 14C mosliciguat 14C mosliciguat Administered orally and via IV
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pharmaron
🇺🇸Baltimore, Maryland, United States
Pharmaron🇺🇸Baltimore, Maryland, United States