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Completed

NCT Number: NCT05999513

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

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.

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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key 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.

Treatment and study plan

casdatifan

Drug

Administered as specified in the treatment arm

Other names: AB521

Primary outcomes

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

    Time frame: Predose, Up to 168 hours postdose

  2. Maximum Concentration (Cmax)

    Time frame: Predose, Up to 168 hours postdose

  3. Time to Maximum Concentration (Tmax)

    Time frame: Predose, Up to 168 hours postdose

  4. Terminal Half-Life Time (t1/2)

    Time frame: Predose, Up to 168 hours postdose

  5. Apparent Total Plasma Clearance (CL/F)

    Time frame: Predose, Up to 168 hours postdose

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

    Time frame: Predose, Up to 168 hours postdose

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Up to 10 weeks

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Registry information

Official study title

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

Acronym: ARC-28

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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