A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin.

Part of paid clinical trials in Brooklyn, Maryland.

Sponsor
AstraZeneca
Study ID
NCT05787002
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • AZD0780 — DRUG
    AZD0780 will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.
  • Rosuvastatin — DRUG
    Rosuvastatin will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.

Study Details

The purpose of the study is to assess the effect of AZD0780 on the pharmacokinetics of rosuvastatin, and to assess the safety and tolerability of AZD0780 single dose, in healthy participants administered alone and in combination with rosuvastatin.

Key Dates

Start date
Mar 9, 2023
Status verified
Apr 2025
Primary completion
May 15, 2023
Completion
May 15, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Treatment sequence A-B
    Participants will receive treatments in the following sequence, a single dose of rosuvastatin tablet alone (Treatment A) in period 1, and then a single dose of rosuvastatin tablet + Dose X AZD0780 tablet (Treatment B) in period 2.
  • Experimental: Treatment sequence B-A
    Participants will receive 1 treatment during each study period in the following sequence: a single dose of rosuvastatin tablet + AZD0780 tablet (Treatment B) in period 1 and then a single dose of rosuvastatin tablet alone (Treatment A) in period 2.

Primary Outcome Measure

Area under plasma concentration-time curve from 0 to infinity (AUCinf) of Rosuvastatin [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteBrooklynMaryland21225-

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Research Site· Brooklyn, MD

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