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GSK2586881 in Participants with Pulmonary Arterial Hypertension


Title 206246 : An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension
Therapeutic Area Pulmonary Hypertension
Principal Investigator Ioana R. Preston, MD
Min Age 18 Years
Max Age 75 Years
Gender Any
Contact Karen Visnaw, RN
617-636-1334
More Information https://www.clinicaltrials.gov/ct2/show/NCT03177603

Overview

The purpose of this study is to test the safety of different doses of the study drug (GSK2586881) to find out if it causes any changes to the pressures inside the heart and lungs of patients who have Pulmonary Arterial Hypertension (PAH).

Study Details

Inclusion Criteria

  • Participant must be between 18-75 years of age (inclusive), at the time of signing the informed consent.

Exclusion Criteria

  • Hospitalization for PAH associated deterioration in the previous 6 months. 

Study Requirements

  • You medical history, PAH history, and current illnesses will be reviewed.
  • Your current medications will be reviewed.
  • Your height and weight will be measured.
  • Your vital signs will be collected (blood pressure, heart rate, and oxygen level).
  • The severity of your PAH will be assessed (WHO Class).
  • Measurement of your exercise capacity (6 Minute Walk Test) and Evaluation of your shortness of breath (Borg Scale).
  • A 40mL (about 3 tablespoons) blood sample will be drawn for clinical laboratory tests.
  • A serum pregnancy test will be performed if you are a woman of child bearing potential. If you are a female and postmenopausal, a blood test may be done to confirm you are not able to get pregnant.
  • A 8.5mL (about 1/2 tablespoon) blood sample if you have Hepatitis B or C or HIV/AIDs. State law requires that the results of positive tests for HIV and hepatitis be reported to a local health agency.
  • A urine sample will be collected for clinical laboratory tests.
  • An EKG (a recording of the electrical activity of your heart) will be performed.
  • You will have a Right Heart Catheterization. A small hallow tube called a catheter will be inserted into your pulmonary artery (this is the major artery that carries blood from your heart to your lungs). Your doctor can observe blood flow through your heart and measure the pressures inside your heart and lungs.
  • You will receive a single intravenous infusion into your arm of the study drug which will take about 3-5 minutes.
  • Approximately 24 hours after you started the study you will be discharged to go home.