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GB001-1101:A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH)

Study category: Heart and Blood Conditions

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Description

This is a multicenter, randomized, blinded and placebo controlled study in subjects with WHO group 1 Pulmonary Arterial Hypertension who will recieve inhaled GB002 or matching placebo for 14 days. The subject will have to visit the clinic for screening and on days 1, 2, 8 and 14. The patient has the option of having a visiting nurse come to them on days 3 to 7 to verify that they are following instrctions for dosing of the study drug and completing their study diary correctly. There will also be a follow up telephone call on days 15 and 42 to assess the patient's physical status and record any additional medications being taken. On day 1 and day 14, the visit will last up to 6 hours and the patient will have 5 blood draws during that time to assess drug levels in the blood and on days 2 and 8, the visi will last up to 2 hours and the patient will have one blood level drawn on these days.

Details
Age

Adult

Eligibility

1) pulmonary hypertension that is idiopathic or due to connective tissue disease or because of anorexigen or methamphetamine use 2) Patient ages between 18 and 75 3) Right heart Cath numbers must meet criteria for the study 4) Must not weigh over 40 kg 5) must be able to do a 6 minute walk test 6) Cannot be participating in another study 7) Cannot have left sided Heart disease 8) Cannot be pregnant or breast feeding 9) Both non-sterile men and women of child bearing potential must be willing to use birthcontrol during the trial 10) Patient cannot be using an inhaler or on a blood thinner

Phase

I - Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Todd Bull,  MD

Todd Bull, MD

Study ID

Protocol Number: 18-2672

ClinicalTrials.gov: NCT03926793

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