NCT06050291

Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and Ezetimibe

A Study to Assess the Effect of Food on the Bioavailability of Obicetrapib and Ezetimibe After Administration of a Fixed-Dose Combination Formulation of Obicetrapib/Ezetimibe, 10 mg/10 mg in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: NewAmsterdam Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will assess the effect of food on the bioavailability of obicetrapib and ezetimibe after a single-dose administration of a fixed-dose combination formulation of obicetrapib/ezetimibe, 10 mg/10 mg in healthy adult male and female subjects under fasted and fed conditions.

Detailed description

This is an open-label, single-dose, randomized, two-treatment, two-period, two-sequence crossover relative bioavailability study under fasted and fed conditions. It will assess the effect of food on the bioavailability of obicetrapib and ezetimibe after a single-dose administration of a fixed-dose combination formulation of obicetrapib/ezetimibe, 10 mg/10 mg in healthy adult male and female subjects under fasted and fed conditions. The screening period will be up to 28 days. Patients that are eligible will enter the clinical facility at least 10.5 hours prior to dosing. Depending on their randomization patients will be fed or fasted prior to dosing. They will remain confined for at least 24 hours. After leaving confinement, patients will return to the clinic 9 times for blood draws. At least 56 days after the first dosing, patients will return to the clinic and go through the same process. Those previously fed before dosing will be fasted and those previously fasted will be fed. Patients will return 9 times after their second confinement for additional blood draws.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	Fixed-Dose Combination (FDC) Tablet	Obicetrapib/Ezetimibe FDC tablet

Timeline

• Start date: 2024-01-20
• Primary completion: 2024-04-07
• Completion: 2024-04-07
• First posted: 2023-09-22
• Last updated: 2024-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study