A Phase 1 Study of Mosliciguat in Healthy, Adult Males

Pulmovant, Inc.

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteer

Treatments: Device: Dry Powder Inhaler; Drug: Mosliciguat; Drug: 14C mosliciguat

Study type: Interventional

Funder types: Industry

Identifiers

NCT07185321

RVT-2301-106

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Mosliciguat (RVT-2301)

Experimental group

Description:

Mosliciguat administered daily via dry powder inhaler.

Treatment:

Device: Dry Powder Inhaler

Drug: Mosliciguat

14C mosliciguat

Experimental group

Description:

Administered orally and via IV

Treatment:

Drug: 14C mosliciguat