NCT05999513

A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers

A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Way Crossover, Pharmacokinetic Study to Evaluate the Relative Bioavailability of AB521 Tablet and Capsule Formulations and the Effect of Food on the Pharmacokinetics of the Tablet Formulation in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Arcus Biosciences, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan tablet versus the casdatifan capsule, and to evaluate the effect of food on the single-dose PK of casdatifan tablet in healthy adult volunteers.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	casdatifan	Administered as specified in the treatment arm

Timeline

• Start date: 2023-08-21
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2023-08-21
• Last updated: 2024-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study