Research Site
Brooklyn, Maryland, 21225, United States
NCT Number: NCT05787002
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Brooklyn, Maryland, 21225, United States
Eligible participants will be randomized, in a 1:1 ratio into 2 of the treatment arms. Each participant will receive 2 treatments in total throughout the study. The following treatments will be given in randomized order in fasting state:
Treatment A: single dose of rosuvastatin tablet alone
Treatment B: single dose of rosuvastatin tablet + AZD0780 tablet
The study will comprise:
Following an overnight fast (minimum 10 hours) participants will receive either of the two treatments and will remain resident in the Clinical Unit until up to 48 hours after dosing of the study drug (up to Day 3).
The total duration of the study will be up to 9 weeks.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
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
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time frame: From Screening (≤ 28 days to Day -2) until Follow-up Visit (10 to 12 days post-final dose)
The safety and tolerability of AZD0780 in combination with rosuvastatin in healthy participants will be assessed.
AstraZeneca
Industry
An Open-label, 2-Period, 2-Sequence Cross-over Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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