A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers
Study Details
Study Description
Brief Summary
The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of AB521 tablet versus the AB521 capsule, and to evaluate the effect of food on the single-dose PK of AB521 tablet in healthy adult volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AB521 - Sequence ABC Participants will sequentially receive AB521 capsules fasted (Treatment A), followed by AB521 tablets fasted (Treatment B), followed by AB521 tablets fed (Treatment C) |
Drug: AB521
Administered as specified in the treatment arm
|
| Experimental: AB521 - Sequence BCA Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A |
Drug: AB521
Administered as specified in the treatment arm
|
| Experimental: AB521 - Sequence CAB Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B |
Drug: AB521
Administered as specified in the treatment arm
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Number of Participants With Adverse Events [Up to 10 weeks]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Celerion, Inc. | Lincoln | Nebraska | United States | 68502 |
Sponsors and Collaborators
- Arcus Biosciences, Inc.
Investigators
- Study Director: Medical Director, Arcus Biosciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ARC-28