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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Arcus Biosciences, Inc.
Study ID
NCT05999513
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • casdatifan — DRUG
    Administered as specified in the treatment arm

Study Details

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.

Key Dates

Start date
Aug 21, 2023
Status verified
May 2024
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Area Under the Plasma Drug Concentration-Time Curve (AUC) [ Time Frame: Predose, Up to 168 hours postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, Inc.LincolnNebraska68502-

Find similar trials in Lincoln, NE

By research site
Celerion, Inc.· Lincoln, NE

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