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Recruiting Phase 1 NCT07455825

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

Trial Parameters

Condition Healthy Participants
Sponsor AstraZeneca
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 64
Sex ALL
Min Age 18 Years
Max Age 55 Years
Start Date 2026-03-05
Completion 2026-06-01
Interventions
AZD5004

Brief Summary

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.

Eligibility Criteria

Main Inclusion Criteria: * Participants suitable veins for cannulation or repeated venipuncture. * All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Female participants: 1. of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, to avoid pregnancy. 2. of non-childbearing potential must be confirmed at the Screening Visit. * Male participants: 1. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods. 2. Additional contraception must be used for the sexual partners of male study participants throughout the clinical study. * Have a Body Mass Index (BMI) of ≥ 23 kg/m2 but not exceeding 35 kg/m2 inclusive (at the time of Screening) and weigh at least 60 kg. Main Exclusion Criteria: * History of any clinically important disease or disorder which, may either put the partic

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