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

NCT05999513 | Completed Phase 1 FDA Drug

• 1 other identifier: ARC-28
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

AB521; casdatifan

Outcome Measures

Primary Outcomes (6)

• Area Under the Plasma Drug Concentration-Time Curve (AUC)

  Predose, Up to 168 hours postdose

• Maximum Concentration (Cmax)

  Predose, Up to 168 hours postdose

• Time to Maximum Concentration (Tmax)

  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

• Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)

  Predose, Up to 168 hours postdose

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  Up to 10 weeks

Study Arms (3)

Casdatifan - Sequence ABC

EXPERIMENTAL

Participants will sequentially receive casdatifan capsules fasted (Treatment A), followed by casdatifan tablets fasted (Treatment B), followed by casdatifan tablets fed (Treatment C)

Drug: casdatifan

Casdatifan - Sequence BCA

EXPERIMENTAL

Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A

Drug: casdatifan

Casdatifan - Sequence CAB

EXPERIMENTAL

Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B

Drug: casdatifan

Interventions

casdatifan DRUG

Administered as specified in the treatment arm

Also known as: AB521

Casdatifan - Sequence ABC; Casdatifan - Sequence BCA; Casdatifan - Sequence CAB

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arcus Biosciences, Inc.: lead

Study Sites (1)

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Description ARC-28 - Public website

Study Officials

• Medical Director

  Arcus Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: August 21, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: October 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (1)