Research Site
Brooklyn, Maryland, 21225, United States
NCT Number: NCT05457270
A study to assess the relative bioavailability and safety of different formulations of AZD4831 in fasted state in healthy volunteers.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Brooklyn, Maryland, 21225, United States
This study will be a randomized, open-label, 2-period, 2-treatment, single-dose, single-center, crossover study conducted at a single Clinical Unit. A total of 30 healthy male and female participants will be randomized to ensure that at least 26 participants are evaluable .
The study will comprise of:
There will be a minimum washout period of at least 14 days from the first dose of AZD4831.
Participants will receive single doses of AZD4831 (2 different formulations) on 2 occasions under fasted conditions.
Participants will be given the following treatments and randomly assigned to the treatment sequence(s): AB, BA
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single oral dose of AZD4831 Formulation A Or a single oral dose of AZD4831 Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of AZD4831 Formulation A Or a single oral dose of AZD4831 Formulation B on Day 1 of Period 2. Each period lasts for 8 days.
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Time frame: Day 1, Day 2 to Day 8 and Day 14
The relative bioavailability of a new AZD4831 formulation compared to the formulation used in an ongoing Phase 2b study and in a couple Phase 1 studies in healthy volunteers will be evaluated.
Time frame: From Screening until Follow up visit (At 14 days post final dose)
The safety and tolerability of single doses of AZD4831 in healthy volunteers will be assessed.
AstraZeneca
Industry
A Randomized, Single-dose, Open-label, Single-center, Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD4831 in Fasted State in Healthy Volunteers.
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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