A Phase 1 Study of Mosliciguat in Healthy, Adult Males

NCT07185321 | Active Not Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: RVT-2301-106
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (4)

• 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

  Baseline, Day 7

• 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

  Urine and fecal recovery of total \[14C\] radioactivity, \[14C\]-mosliciguat

  Baseline, Day 28

• Maximum observed concentration (Cmax)

  Baseline, Day 7

Secondary Outcomes (1)

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

  Baseline, Day 44

Study Arms (2)

Mosliciguat (RVT-2301)

EXPERIMENTAL

Mosliciguat administered daily via dry powder inhaler.

Drug: Mosliciguat; Device: Dry Powder Inhaler

14C mosliciguat

EXPERIMENTAL

Administered orally and via IV

Drug: 14C mosliciguat

Interventions

Mosliciguat DRUG

Dose level for inhalation

Mosliciguat (RVT-2301)

14C mosliciguat DRUG

Dose level

14C mosliciguat

Dry Powder Inhaler DEVICE

Dry powder inhaler for mosliciguat

Mosliciguat (RVT-2301)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pulmovant, Inc.: lead

Study Sites (1)

Pharmaron

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Dry Powder Inhalers

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies

Study Officials

• Ubaldo Martin

  Pulmovant, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 22, 2025
• Study Start: June 10, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)