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OpenTrials
Completed

NCT Number: NCT06193031

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy Participants

The primary purpose of this study is to determine the safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USA001

Los Angeles, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Have a body weight between 50 and 120 kg (females) or between 55 and 120 kg (males), inclusive, with a body mass index (BMI) between 19.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, at screening.
  • Have a medical history, physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at screening.
  • Do not take any systemic or topical prescription, or nonprescription (over-the-counter [OTC]) medication (acetaminophen or ibuprofen are permitted upon principal investigator [PI] discretion) within 2 weeks or 5 half-lives (whichever is longer) before first dose of the study drugs until discharge from the study (unless prescribed by the Investigator to treat an AE).
  • Agree to abstain from consuming alcohol at least 3 days prior to in-clinic confinement until discharge from the study.

Exclusion criteria

  • Have a history of anaphylaxis, a previous documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
  • Have a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
  • Have a history of orthostatic hypotension, or unexplained syncope.
  • Have a history of additional risk factors for Torsades de Pointes (eg, heart failure, family history of Long QT Syndrome).
  • Are positive for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg), or the hepatitis C virus (HCV) antibody at screening.
  • Are users or former users of nicotine-containing products with > 10 pack-years of tobacco use history (including but not limited to cigarettes, cigars, and chewing or dipping tobacco), or users who stopped use or consumption (i.e., smoking, chewing, or pinching) of these nicotine-containing products less than 6 months before study drug administration or were using or had used topical or oral nicotine preparations for smoking cessation within the past 3 months before study drug administration.
  • Have a history of alcohol abuse or a history of or current impairment of organ function reasonably related to alcohol abuse.
  • Have a history or current evidence of abuse of licit or illicit drugs or a positive urine test for drugs of abuse.
  • Have a history of abnormal bleeding tendencies.
  • Donated any plasma within 7 days prior to first dosing, or has donated blood in excess of 450 mL, or had significant blood loss within 56 days prior to first dosing.
  • Have any flu-like syndrome or other respiratory infection within 2 weeks of Day 1 or having been vaccinated with an attenuated live virus within 4 weeks of Day 1.
  • Have a history of major surgery within 4 weeks or minor surgery within 2 weeks of screening.

Note: Other inclusion/exclusion criteria may apply.

Treatment and study plan

C16TR

Drug

Administered as inhalation using a Philips Micro device inhaler.

Other names: Hexadecyl-treprostinil

Placebo

Drug

Phosphate buffered saline (PBS) administered using Philips Micro device inhaler.

Tyvaso®

Drug

Administered as inhalation.

Other names: Inhaled treprostinil

Primary outcomes

  1. Number of Participants who Experienced an Adverse Event (AE)

    Time frame: Up to 32 days

    Safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.

Secondary outcomes

  1. Area Under the Plasma Concentration-time Curve (AUC) of Treprostinil and C16TR Post C16TR for Inhalation Dose

    Time frame: At multiple timepoints post dose on Days 2 to 4

  2. Cohort 1: AUC of Treprostinil Post Tyvaso® Dosing

    Time frame: At multiple timepoints post dose on Days 1 and 2 for Cohort 1

    Pharmacokinetics of treprostinil after Tyvaso® dosing in healthy participants will be assessed.

  3. Mean Change From Baseline in Corrected QT Interval by Fridericia (QTcF) for C16TR

    Time frame: Baseline up to Day 4 (Cohort 1) and Day 3 (Cohorts 2, 3, 4, and 5)

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study of C16TR for Inhalation to Determine Its Safety, Tolerability, and Pharmacokinetics With an Open-label Tyvaso® Cohort in Healthy Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 5, 2024
Registry last updated
Jan 5, 2024

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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