Research Site
Brooklyn, Maryland, 21225, United States
NCT Number: NCT05630677
This study will estimate the relative bioavailability of AZD5055 film-coated tablet as compared to AZD5055 oral suspension. The study will also assess the absolute bioavailabilty of AZD5055 and the effect of food and an acid reducing agent, rabeprazole, on the PK of AZD5055 film-coated tablets when given with food (fed state) or without food (fasted state).
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Brooklyn, Maryland, 21225, United States
This will be an Open-Label, Five-Period Study in healthy subjects. The study will comprise of a Screening Period of maximum 28 days.
The treatment groups are as follows:
Five (5) periods during which subjects will participate from Day -1 of Period 1 to 72 hours after the AZD5055 dose in Period 5.
A Follow-up Visit, or telephone call, approximately 6 days after the last AZD5055 dose in Period 5.
There will be a minimum washout of 3 days between the AZD5055 dose administration in Period 1 and Period 2 and a minimum washout of 4 days between AZD5055 doses administrations for subsequent study periods.
Each subject will participate in the study for approximately 8 weeks.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive a single dose intravenous infusion of AZD5055 as 20-minute infusion on Day 1 of the respective period in overnight fasted state.
Subjects will receive single dose of AZD5055 oral suspension on Day 1 of the respective period in overnight fasted state.
Subjects will receive single oral dose of AZD5055 film-coated tablets on Day 1 of the respective period in overnight fasted state.
Subjects will receive oral doses of rabeprazole twice daily 3 days prior to AZD5055 single dose and 4 days after the AZD5055 single dose including the day that AZD5055 is dosed under fasted conditions [Study Day 10 to 18].
Time frame: Day 1-6, 8-10, 13-15, 17-19
Time frame: Day 1-6, 8-10, 13-15, 17-19
Time frame: Day 1-6, 8-10, 13-15, 17-19
AstraZeneca
Industry
An Open-Label, Five-Period Study in Healthy Subjects to Investigate the Relative Bioavailability of AZD5055 Film-Coated Tablet Versus AZD5055 Oral Suspension Formulation, the Absolute Oral Bioavailability of AZD5055 and to Evaluate the Effect of Food and an Acid Reducing Agent on the Pharmacokinetics of AZD5055.
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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