Healthy ParticipantsPhase 1ARC-28NCT05999513
A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers
A Phase 1 study testing casdatifan in people with Healthy Participants, run by Arcus Biosciences, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- casdatifan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 31 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- casdatifan
- Keywords
- AB521, casdatifan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
casdatifanDrug
Also called AB521
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: casdatifan |
| Casdatifan - Sequence BCA | Experimental | Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A Receives: Drug: casdatifan |
| Casdatifan - Sequence CAB | Experimental | Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B Receives: Drug: casdatifan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Drug Concentration-Time Curve (AUC)
Measured: Predose, Up to 168 hours postdose
Maximum Concentration (Cmax)
Measured: Predose, Up to 168 hours postdose
Time to Maximum Concentration (Tmax)
Measured: Predose, Up to 168 hours postdose
Terminal Half-Life Time (t1/2)
Measured: Predose, Up to 168 hours postdose
Apparent Total Plasma Clearance (CL/F)
Measured: Predose, Up to 168 hours postdose
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Measured: Predose, Up to 168 hours postdose
Secondary outcomes (1)
Number of Participants With Adverse Events
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start21 Aug 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999513
- Sponsor's protocol ID
- ARC-28
- Acronym
- ARC-28
- Status last verified
- May 2024
- First submitted
- 14 Aug 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05999513
- Acronym / sponsor ID
- ARC-28 / ARC-28
- Conditions
- Healthy Participants
- Keywords
- AB521, casdatifan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Casdatifan - Sequence ABC | Experimental | Drug: casdatifanParticipants 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 | Experimental | Drug: casdatifanParticipants will sequentially receive Treatment B, followed by Treatment C, then Treatment A |
| Casdatifan - Sequence CAB | Experimental | Drug: casdatifanParticipants will sequentially receive Treatment C, followed by Treatment A, then Treatment B |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| casdatifanAlso: AB521Administered as specified in the treatment arm | Drug | Casdatifan - Sequence ABC, Casdatifan - Sequence BCA, Casdatifan - Sequence CAB |
Primary outcome
Area Under the Plasma Drug Concentration-Time Curve (AUC)
Time frame: Predose, Up to 168 hours postdose
Maximum Concentration (Cmax)
Time frame: Predose, Up to 168 hours postdose
Time to Maximum Concentration (Tmax)
Time frame: Predose, Up to 168 hours postdose
Terminal Half-Life Time (t1/2)
Time frame: Predose, Up to 168 hours postdose
Apparent Total Plasma Clearance (CL/F)
Time frame: Predose, Up to 168 hours postdose
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Time frame: Predose, Up to 168 hours postdose
1 secondary outcome
Number of Participants With Adverse Events
Time frame: Up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Description ARC-28 - Public websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
Related trials for Healthy Participants
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Arcus Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing casdatifan in people with Healthy Participants, run by Arcus Biosciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Drug Concentration-Time Curve (AUC) (time frame: Predose, Up to 168 hours postdose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.