A Phase 1 Study of Mosliciguat in Healthy, Adult Males

NCT ID: NCT07185321

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2026-05-31

Brief Summary

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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

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mosliciguat (RVT-2301)

Mosliciguat administered daily via dry powder inhaler.

Group Type EXPERIMENTAL

Mosliciguat

Intervention Type DRUG

Dose level for inhalation

Dry Powder Inhaler

Intervention Type DEVICE

Dry powder inhaler for mosliciguat

14C mosliciguat

Administered orally and via IV

Group Type EXPERIMENTAL

14C mosliciguat

Intervention Type DRUG

Dose level

Interventions

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Mosliciguat

Dose level for inhalation

Intervention Type DRUG

14C mosliciguat

Dose level

Intervention Type DRUG

Dry Powder Inhaler

Dry powder inhaler for mosliciguat

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pulmovant, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ubaldo Martin

Role: STUDY_DIRECTOR

Pulmovant, Inc.

Locations

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Pharmaron

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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RVT-2301-106

Identifier Type: -

Identifier Source: org_study_id

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