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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06193031
• Other study ID #: INS1009-101
• Status: Completed
• Phase: Phase 1
• Start date: November 17, 2015
• Est. completion date: December 18, 2015

Study information

• Verified date: December 2023
• Source: Insmed Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 18, 2015
• Est. primary completion date: December 18, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Respiratory Aspiration

Intervention

Drug:
• C16TR
Administered as inhalation using a Philips Micro device inhaler.
• Placebo
Phosphate buffered saline (PBS) administered using Philips Micro device inhaler.
• Tyvaso®
Administered as inhalation.

Locations

Country	Name	City	State
United States	USA001	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who Experienced an Adverse Event (AE)	Safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.	Up to 32 days
Secondary	Area Under the Plasma Concentration-time Curve (AUC) of Treprostinil and C16TR Post C16TR for Inhalation Dose		At multiple timepoints post dose on Days 2 to 4
Secondary	Cohort 1: AUC of Treprostinil Post Tyvaso® Dosing	Pharmacokinetics of treprostinil after Tyvaso® dosing in healthy participants will be assessed.	At multiple timepoints post dose on Days 1 and 2 for Cohort 1
Secondary	Mean Change From Baseline in Corrected QT Interval by Fridericia (QTcF) for C16TR		Baseline up to Day 4 (Cohort 1) and Day 3 (Cohorts 2, 3, 4, and 5)

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