A Phase I, Randomized, Single-dose, 3-Period, Open-Label Study to Assess the Pharmacokinetic Formulation Bridging, Safety, and Food Effect of Different Oral Formulations of AZD5004 in Healthy Participants
AstraZeneca
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.
Description
This is a Phase I, randomized, single-dose, 2 part, 3-period, open-label study. There will be 2 Parts (Part A and Part B). In each part, participants will be randomized to a treatment sequence in each cohort. In Period 1, participants in Part A and Part B will receive Regimen A (AZD5004 Formulation 1 \[reference\]). In Periods 2 and 3, participants in Part A will receive Regimen B or Regimen C (AZD5004 Formulation 5) and participants in Part B will receive Regimen D or Regimen E per assigned treatment sequence. The study will comprise: * A Screening Period of maximum 28 days * 3 Treatment P…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
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 a…
Interventions
- DrugAZD5004
AZD5004 will be administered orally.
Locations (2)
- Research SiteGlendale, California
- Research SiteBaltimore, Maryland