Phase 1 PK study of Ralinepag XR Tablet in healthy subjects QCL118149
Research type
Research Study
Full title
An Open Label, Multiple-Dose, Titration Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ralinepag Extended Release Tablet in Fed and Fasted Healthy Volunteers
IRAS ID
230849
Contact name
Brian Raether
Contact email
Sponsor organisation
Arena Pharmaceuticals, Inc
Eudract number
2017-002639-40
Duration of Study in the UK
0 years, 2 months, 16 days
Research summary
The Sponsor is developing the study drug, Ralinepag, for the treatment of pulmonary arterial hypertension (PAH). PAH is a condition characterised by high blood pressure in the blood vessels supplying the lungs. The walls of the pulmonary arteries become thick and stiff, and can’t expand as well causing reduced blood flow. This causes the right-hand side of your heart to continually work harder, it can gradually become weaker, which can lead to heart failure.\n\nThe study will try to identify the levels of ralinepag in the blood after increasing doses of new slow release ralinepag tablets. The safety and tolerability of increasing doses of the new ralinepag tablets will also be investigated. Ralinepag works by relaxing the small muscles in the wall of the blood vessels in the heart and lungs causing them to dilate (widen) and also stops a type of blood cell (platelets) from accumulating in the blood vessels.\n\nThe study will involve two cohorts (groups) of subjects, each cohort will include up to 18 healthy male and female subjects. Each subject will receive a once daily dose of ralinepag starting from a dose of 60µg for 5 days, and increasing every 5 days up to a maximum dose of 300µg. The subjects will receive a total of 25 doses. Prior to any dose increases, thorough examination of the safety data from the previous dose level will be assessed before the increased dose will be given. Cohort 1 will be dosed in the fasted state, whereas cohort 2 will be dosed in the fed state. Subjects will remain in the clinic until 72 hours after the last dose of study drug (Day 28). A follow up phone call will take place 5 to 7 days after the subject’s last dose to ensure the continued wellbeing of the subjects.
REC name
HSC REC B
REC reference
17/NI/0131
Date of REC Opinion
1 Aug 2017
REC opinion
Further Information Favourable Opinion