A comparative BA study to evaluate PK of Ralinepag XR (QCL117837)
Research type
Research Study
Full title
A Phase 1 Comparative Bioavailability Study in Healthy Male and Female Subjects Designed to Evaluate the Pharmacokinetic Profile of Ralinepag following Single Dose Administration of an Extended Release Prototype Formulation
IRAS ID
219080
Contact name
Brian Raether
Contact email
Sponsor organisation
Arena Pharmaceuticals, Inc
Eudract number
2016-004659-61
Duration of Study in the UK
0 years, 1 months, 16 days
Research summary
The Sponsor is developing Ralinepag, an investigational drug (‛study drug’) for the potential treatment of pulmonary arterial hypertension (PAH). PAH is a condition that affects the blood vessels supplying and within the lungs. In this disease, these blood vessels become narrower, leading to an increase in the blood pressure in the lungs. This can cause initial symptoms such as breathlessness and dizziness. Over time, these vessels become thicker and stiffer, and the heart becomes less able to pump blood to and through the lungs. If left untreated, the disease results in right heart failure and can lead to death.\n\nThe sponsor is developing a tablet that slowly releases Ralinepag into the body (an extended release or XR tablet) after it has been swallowed. The main purpose of this study is to see how the drug from the XR tablet is absorbed into and circulates within the body, how it is broken down, and how it is removed (excreted) from the body. These parameters will be evaluated when the drug is given at up to three different doses. The study will also assess how much of the drug is absorbed and circulates when given as an XR tablet as compared to the drug made up in an immediate release (IR) capsule.\n\nThe study will consist of 7 study periods involving up to 24 healthy male and female subjects. The study will include 2 cohorts (groups) with 12 subjects in each. In Cohort 1, subjects will receive a total dose of either 0.03, 0.06, 0.12 or 0.18 mg of Ralinepag in either an IR capsule or an XR tablet, over 4 treatment periods. In Cohort 2, subjects will receive, as a reference, up to three doses of an approved drug (an oral tablet) over 3 treatment periods. Samples of blood will be collected from each subject in both cohorts throughout the study to measure the concentration of the drug at various points in time.\n
REC name
HSC REC A
REC reference
17/NI/0009
Date of REC Opinion
10 Feb 2017
REC opinion
Further Information Favourable Opinion