This is a Phase 2b, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy, safety and tolerability of IKT-001 self administered orally once daily in participants with PAH. The 26 week treatment period is designed to demonstrate the efficacy, safety and tolerability of IKT-001. The primary objective of the study is to evaluate the effect of treatment with IKT on pulmonary vascular resistance and to evaluate the safety and tolerability of two doses in participants with PAH.
A Phase 2b Study of IKT-001 in Pulmonary Arterial Hypertension
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial of IKT-001 in Pulmonary Arterial Hypertension
Pulmonary hypertension
All genders
18-75
Recruiting now
Overview
Principal Investigator: Harrison Farber, MD
Contact Us
Mary Hays
Study details
Inclusion Criteria
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Men and women 18 and 75 years of age (inclusive) at the time of signing the ICF.
- Must have a body mass index (BMI) of greater than or equal to 18.5 kg/m(squared) and less than or equal to 35 kg/m(squared) at screening
Exclusion Criteria
- Diagnosis of PAH WHO Groups 2,3,4, or 5
- History of restrictive, constrictive or congestive cardiomyopathy
- Personal or family history of long QT syndrome or sudden cardiac death
Study Requirements
The length of participation will be 26 weeks consisting of seven research visits. PK will be done at Visits 1, 5 and 7. Nt-proBNP will be done at Visits 1, 3, 5 and 7. IL-6 is done at Visits 1 and 7.Hba1c is done at screening. Safety laboratory tests will be done at all visits. The total volume of blood taken at each visit will be about 4-5 teaspoons. There are no x-rays, CT scans or MRIs.