Safety, pharmacokinetics (PK) and relative bioavailability of NTP42:KVA4 oral formulations
Research type
Research Study
Full title
A Phase 1, randomised, open-label, 3-way crossover study to evaluate the safety, tolerability, pharmacokinetics (including food effect), and relative bioavailability of NTP42:KVA4 administered as a drug-in-capsule, compared with an oral suspension, in healthy volunteers
IRAS ID
1008376
Contact name
Therese Kinsella
Contact email
Sponsor organisation
ATXA Therapeutics Limited
Research summary
NTP42:KVA4 (the study medicine) is an experimental new medicine for treating pulmonary arterial hypertension (PAH) – high blood pressure in the vessels that carry blood from the heart to the lungs.
In people with PAH, the walls of these blood vessels become stiff and thickened, so blood flows through them more slowly. This makes it harder for the heart to pump blood so the blood pressure inside the vessels increases. Over time this can cause serious damage to the heart, which can lead to death. People with PAH may suffer a wide range of symptoms, including shortness of breath, tiredness, dizziness, palpitations (awareness of heartbeat), swelling in the legs and feet, and chest pain.
Current treatments for PAH improve symptoms but do not treat the cause of the disease – the changes to the blood vessels that carry blood from the heart to the lungs. We hope that the study medicine will work by blocking a substance that causes these changes.
In previous studies in healthy volunteers, NTP42:KVA4 was taken in liquid form. But it would be more convenient for patients to take it as capsules. We’ll test single doses of the study medicine in up to 12 healthy volunteers (aged 18–55) to compare 2 forms of the study medicine: an existing liquid form and a new capsule form.
We aim to find out the side effects and blood levels of the study medicine, how similar the liquid and capsule forms are, and if food affects how much study medicine gets into the bloodstream when given as a capsule.
Participants will have 3 study sessions, and take up to 4 weeks to finish the study. First, they’ll have a screening visit. In each study session, they’ll stay on the ward for 2 nights in a row and make 2 outpatient visits. Then they’ll have a final follow-up visit about a week after their last dose.
A pharmaceutical company ATXA Therapeutics Limited is funding the study.
The study will take place at 1 centre in London.
REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0641
Date of REC Opinion
20 Oct 2023
REC opinion
Further Information Favourable Opinion