Food Effects on the Pharmacokinetics of Single Dose and Steady-State Ralinepag, a Novel Oral Prostacyclin Agonist, in Healthy Volunteers.

In 30 seconds

This Phase I clinical trial assessed the pharmacokinetics and safety of ralinepag extended-release in healthy volunteers, comparing fed and fasted states. The study found minimal differences in pharmacokinetic parameters between the two conditions, with a 2.1-fold accumulation after 5 days of dosing at 60 μg.

Key findings

• Ralinepag XR showed minimal pharmacokinetic differences between fed and fasted states.
• There was a 2.1-fold accumulation of ralinepag after 5 days of dosing at 60 μg.
• Median time to maximum concentration (T max) was 4-10 hours at steady state.
• No serious adverse events were reported, with headache, jaw pain, and nausea being the most common.

Why it matters

Understanding the pharmacokinetics of ralinepag XR in different feeding states is crucial for optimizing dosing strategies in patients with pulmonary arterial hypertension, ensuring effective treatment while minimizing adverse effects.