Orlando, FLNCT07643155Now EnrollingIRB Ready

Hepatic Impairment Clinical Trial in Orlando, FL

Access cutting-edge hepatic impairment treatment through this phase 1 clinical trial at a research site in Orlando. Study-provided care at no cost to qualified participants.

Sponsored by Insmed Incorporated

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Expert Care in Orlando

Access hepatic impairment specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hepatic impairment treatment provided free

Apply for This Orlando Location

Check if you qualify for this hepatic impairment clinical trial in Orlando, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Orlando

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Orlando site if eligible
  4. 4Begin participation

About This Hepatic Impairment Study in Orlando

The primary purpose of the study is to determine the effect of mild, moderate, and severe hepatic impairment on the PK of total treprostinil palmitil (TP) and treprostinil (TRE) following a single dose of 80 micrograms (μg) TPIP, when compared to normal hepatic function.

Sponsor: Insmed Incorporated

Who Can Participate

Inclusion Criteria

Body mass index between 18.0 and 40.0 kilograms per square meter (kg/m\^2), inclusive. Inclusion Criteria for Participants with Normal Hepatic Function
In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements, and clinical laboratory assessments (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in, as assessed by the investigator (or designee). Inclusion Criteria for Participants With Hepatic Impairment:
Diagnosis of chronic (\>6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history.
Participants with type 2 diabetes mellitus may be included, if they have:
glycosylated hemoglobin A1C ≤8.5% at screening
fasting blood glucose ≤240 milligrams per deciliter (mg/dL), while participant is using their normal diabetes medication, at screening and check-in.

Exclusion Criteria

History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair are allowed).
Use or intend to use any moderate or strong inducers or inhibitors of CYP2C8 or CYP2C9 within 30 days prior to dosing.
Participation in a clinical trial involving administration of an investigational medicinal product (IMP) (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer. Exclusion Criteria for Participants with Normal Hepatic Function
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in. Results that are compatible with marijuana use are not exclusionary. Exclusion Criteria for Participants With Hepatic Impairment:
Current organ transplant or waiting for organ transplant scheduled to occur during the trial.
Hospitalization for hepatic encephalopathy within 3 months prior to dosing.
Encephalopathy ≥Grade 2.
History of drug/chemical abuse within 1 year prior to check-in. Marijuana use is not exclusionary. Note: Other protocol-defined inclusion/exclusion criteria may apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT07643155) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hepatic Impairment Treatment Options in Orlando, FL

If you're searching for hepatic impairment treatment options in Orlando, FL, this clinical trial (NCT07643155) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced hepatic impairment specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hepatic impairment clinical trials near you to find additional studies recruiting in your area.

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