This Study evaluates the pharmacokinetic (PK) profile of different zamicastat doses in Pulmonary arterial hypertension (PAH) patients to find the most promising therapeutic dosage range for the treatment of PAH disease
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female patients aged 18 to 70 years.
. Able to comprehend and willing to sign an informed consent form.
. Diagnosis of PAH (pulmonary arterial hypertension WHO Group 1), documented by right heart catheterisation with a mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, a pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) \> 3 wood unit (WU):
. Idiopathic, in non-vasoreactive patients
. Heritable: Bone morphogenetic protein receptor type II (BMPR2) mutation and other mutations, in non-vasoreactive patients
. Drugs and toxin induced, in non-vasoreactive patients
. Associated with connective tissue disease
. Associated with simple congenital defects (atrial septal defect and/or ventricular septal defect) if closed \> 12 months before inclusion.
Exclusion criteria
. Contraindication to zamicastat, i.e. known hypersensitivity to ingredients of zamicastat formulation.
. Two or more consecutive measurements of systolic blood pressure (SBP) \< 95 mmHg or diastolic blood pressure (DBP) \< 50 mmHg.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Curve 0-24h (AUC0-24h) (ng.h/mL) - 50 mg
Timeframe: Day 1 (0 hours and then 1, 2, 4, 8, 16 and 24 hours after investigational medicinal product (IMP) intake)
2
Area Under the Curve 0-24h (AUC0-24h) (ng.h/mL/mg) - HTD
Timeframe: 1, 2, 4, 8, 16 and 24 hours after IMP intake
3
Maximum Plasma Concentration (Cmax) (ng/mL) - 50 mg
Timeframe: Day 1 (0 hours and then 1, 2, 4, 8, 16 and 24 hours after IMP intake)
4
Maximum Plasma Concentration (Cmax) (ng/mL/mg) - HTD
Timeframe: 1, 2, 4, 8, 16 and 24 hours after IMP intake
5
Time Until Cmax (Tmax) (h) - 50 mg
Timeframe: Day 1 (0 hours and then 1, 2, 4, 8, 16 and 24 hours after IMP intake)
6
Time Until Cmax (Tmax) (h) - HTD
Timeframe: 1, 2, 4, 8, 16 and 24 hours after IMP intake
7
Minimum Plasma Concentration at the End of the Dosing Interval (Cmin,SS) (ng/mL/mg) - HTD
. Uncontrolled diabetes mellitus with HbA1c ≥ 8.5% within the last three months or at screening.
. PAH WHO Group 1 due to portal hypertension, human immunodeficiency virus (HIV) infection and schistosomiasis.
. Any disease known to cause pulmonary hypertension other than PAH WHO Group 1.
. Obstructive lung disease: Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) \< 60% and FEV1 \< 60% of predicted value after bronchodilator administration.
. Restrictive lung disease: Total Lung Capacity (TLC) \< 70% of predicted value.
. History of moderate to severe hepatic impairment (Child-Pugh B and C).
Timeframe: 1, 2, 4, 8, 16 and 24 hours after IMP intake