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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: casdatifan

• Registration Number: NCT05999513
• Lead Sponsor: Arcus Biosciences, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study Start: 2023-08-21
• Study First Posted: 2023-08-21
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on volunteer self-reporting
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilogram (kg)/square meter (m^2) at the screening visit, with body weight ≥ 45 kg
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the study physician
• Able to swallow multiple capsules and tablets
• Has adequate peripheral venous access

Key

Exclusion Criteria

• Has active neoplastic disease or history of neoplastic disease within 5 years of the screening visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
• Has abnormal liver enzyme test results or hematology values at the time of enrollment
• Has a history of additional risk factors for Torsades de pointes (example: heart failure, hypokalemia, family history of Long QT Syndrome)
• Malabsorption condition that would alter the absorption of orally administered medications at the discretion of the study physician
• Participation in another clinical study within 90 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Casdatifan - Sequence ABC	casdatifan	Participants will sequentially receive casdatifan capsules fasted (Treatment A), followed by casdatifan tablets fasted (Treatment B), followed by casdatifan tablets fed (Treatment C)
Casdatifan - Sequence BCA	casdatifan	Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A
Casdatifan - Sequence CAB	casdatifan	Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Drug Concentration-Time Curve (AUC)	Predose, Up to 168 hours postdose
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)	Predose, Up to 168 hours postdose
Maximum Concentration (Cmax)	Predose, Up to 168 hours postdose
Terminal Half-Life Time (t1/2)	Predose, Up to 168 hours postdose
Apparent Total Plasma Clearance (CL/F)	Predose, Up to 168 hours postdose
Time to Maximum Concentration (Tmax)	Predose, Up to 168 hours postdose

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	Up to 10 weeks

Trial Locations

Locations (1)

Celerion, Inc.; 🇺🇸 Lincoln, Nebraska, United States