Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInhibikase Therapeutics
About this trial
This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily.
Eligibility criteria
Qualifiers
Capable of giving signed informed consent.
Participants who have completed Study IKT-001-201 or any other Phase 2 or 3 controlled clinical study with IKT-001.
Disqualifiers
ALT or AST levels >3× the ULN
Bilirubin levels >2× the ULN
ANC <1.2 ×10^9 cells/L, hemoglobin <9 g/dL, hematocrit <30%, or platelets <75 × 10^9 cells/L
Absolute eGFR <30 mL/min using creatinine or cystatin C as defined by the CKD-EPI equation (2021)
Trial design
Treatments tested in this trial
- IKT-001
Treatment groups
484 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov