A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT07455825
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • AZD5004 — DRUG
    AZD5004 will be administered orally.

Study Details

The purpose of this study is to assess the pharmacokinetics (PK), safety and tolerability of different oral formulations of AZD5004, and to evaluate the effect of food on these formulations in healthy participants.

Key Dates

Start date
Mar 5, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

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

Arms

  • Experimental: Cohort A: Treatment Sequence ABC
    Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen B (formulation 5, fasted state), followed by Regimen C (formulation 5, fed state) of AZD5004.
  • Experimental: Cohort A: Treatment Sequence ACB
    Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen C (formulation 5, fed state), followed by Regimen B (formulation 5, fasted state) of AZD5004.
  • Experimental: Cohort B: Treatment Sequence ADE
    Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen D (formulation 6, fasted state), followed by Regimen E (formulation 6, fed state).
  • Experimental: Cohort B: Treatment Sequence AED
    Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen E (formulation 6, fed state), followed by Regimen D (formulation 6, fasted state).

Primary Outcome Measure

Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf) [ Time Frame: From Day 1 to Day 22 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-
Research SiteBaltimoreMaryland21225-

Find similar trials in Glendale, CA

By research site
Research Site· Glendale, CAResearch Site· Baltimore, MD

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