Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile With Oral AB521 in Healthy Volunteers

Sponsor
Arcus Biosciences, Inc.
Study ID
NCT05117554
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • casdatifan — DRUG
    Capsule
  • Placebo — DRUG
    Capsule
  • Midazolam — DRUG
    Syrup solution

Study Details

This study will evaluate the safety and tolerability, pharmacokinetic, and pharmacodynamic profile, and drug-drug interaction (DDI) of casdatifan in healthy participants.

Key Dates

Start date
Nov 9, 2021
Status verified
May 2024
Primary completion
Feb 17, 2023
Completion
Feb 17, 2023

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SAD-casdatifan Dose 1
    Participants will receive "Dose 1" of casdatifan orally with water under fasting conditions.
  • Experimental: SAD-casdatifan Dose 2
    Participants will receive "Dose 2" of casdatifan orally with water under fasting conditions.
  • Experimental: SAD-casdatifan Dose 3
    Participants will receive "Dose 3" of casdatifan orally with water under fasting conditions.
  • Experimental: SAD-casdatifan Dose 4
    Participants will receive "Dose 4" of casdatifan orally with water under fasting conditions.
  • Placebo Comparator: SAD-Placebo
    Participants will receive matching placebo orally with water under fasting conditions.
  • Experimental: MAD-casdatifan Dose 1
    Participants will receive "Dose 1" of casdatifan orally with water under fasting conditions.
  • Experimental: MAD-casdatifan Dose 2
    Participants will receive "Dose 2" of casdatifan orally with water under fasting conditions.
  • Placebo Comparator: MAD-Placebo
    Participants will receive matching placebo orally with water under fasting conditions.
  • Experimental: DDI-casdatifan Dose + Midazolam
    Participants will receive highest safe dose level of casdatifan from MAD and midazolam orally with water under fasting conditions

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 21.5 Weeks ]

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