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Completed

NCT Number: NCT07185321

A Phase 1 Study of Mosliciguat in Healthy, Adult Males

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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Key information

Conditions

Healthy Volunteer

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mosliciguat

Drug

Dose level for inhalation

14C mosliciguat

Drug

Dose level

Dry Powder Inhaler

Device

Dry powder inhaler for mosliciguat

Primary outcomes

  1. 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

  2. Area under the concentration-time curve (AUC) for mosliciguat

    Time frame: Baseline, Day 7

  3. 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

  4. Maximum observed concentration (Cmax)

    Time frame: Baseline, Day 7

Secondary outcomes

  1. Evaluate the incidence of Treatment-Emergent Adverse Events (safety and tolerability of mosliciguat)

    Time frame: Baseline, Day 44

    Incidence, nature, and severity of participant TEAEs, SAEs, and AEs

Sponsors and collaborators

Lead sponsor

Pulmovant, Inc.

Industry

Registry information

Official study title

An Open-Label, Phase 1 Study to Investigate the Absolute Bioavailability and the Absorption, Metabolism, and Excretion of [14C]-Mosliciguat in Healthy, Adult Males

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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