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

NCT ID: NCT06193031

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-17
• Study Completion Date: 2015-12-18

Brief Summary

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo

Participants received a single dose of Tyvaso® on Day 1, then randomized to receive either a single dose of C16TR for inhalation (Dose A) or matching placebo on Day 2 in Cohort 1.

Group Type: EXPERIMENTAL

C16TR

Intervention Type: DRUG

Administered as inhalation using a Philips Micro device inhaler.

Placebo

Intervention Type: DRUG

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

Tyvaso®

Intervention Type: DRUG

Administered as inhalation.

Cohort 2: C16TR Dose B or Placebo

Participants were randomized to receive a single dose of C16TR for inhalation (Dose B) or matching placebo on Day 1 in Cohort 2.

Group Type: EXPERIMENTAL

C16TR

Intervention Type: DRUG

Administered as inhalation using a Philips Micro device inhaler.

Placebo

Intervention Type: DRUG

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

Cohort 3: C16TR Dose C or Placebo

Participants were randomized to receive a single dose of C16TR for inhalation (Dose C) or matching placebo on Day 1 in Cohort 3.

Group Type: EXPERIMENTAL

C16TR

Intervention Type: DRUG

Administered as inhalation using a Philips Micro device inhaler.

Placebo

Intervention Type: DRUG

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

Interventions

C16TR

Administered as inhalation using a Philips Micro device inhaler.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Tyvaso®

Administered as inhalation.

Intervention Type: DRUG

Other Intervention Names

Hexadecyl-treprostinil; Inhaled treprostinil

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insmed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USA001

Los Angeles, California, United States

Countries

United States

Other Identifiers

INS1009-101

Identifier Type: -

Identifier Source: org_study_id