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Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil

NCT03399604 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2024-07-30

Study results available
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Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH).

Conditions

  • Primary Pulmonary Hypertension

Interventions

DRUG

LIQ861 Inhaled Treprostinil

LIQ861 bulk powder is generated from a treprostinil/excipient matrix from which particles of precise size and shape are created and filled into a hydroxypropyl methylcellulose (HPMC) capsule (size 3). LIQ861 capsules are provided in capsule strengths of 25 μg, 50 μg, 75 μg and 100 μg treprostinil.

Sponsors & Collaborators

  • Nuventra, Inc.

    collaborator INDUSTRY

  • Liquidia Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Nicholas S Hill, MD · Tufts Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2019-05-06
Completion
2019-11-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03399604 on ClinicalTrials.gov