A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD3974 After Single and Multiple Ascending Dosing to Healthy Participants
AstraZeneca
Summary
The purpose of this study is to assess the safety and tolerability of AZD3974 and characterize the pharmacokinetics (PK) of AZD3974 following oral administration to healthy participants, including participants of Japanese and Chinese descent.
Description
This is a first in human, randomized, single-blind, placebo-controlled study. It consists of two parts. Part A (single ascending dose - SAD): This study part will enroll six cohorts (plus two optional additional cohorts) of healthy participants (Part A1), three cohorts (plus one optional additional cohort) of healthy Japanese participants (Part A2) and one cohort (plus one optional additional cohort) of healthy Chinese participants (Part A3). Cohort 3 of Part A1 will be extended to evaluate the effect of food intake on the PK of AZD3974. In Part A (all cohorts), participants will receive a si…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture at the Screening Visit. * All females must have a negative pregnancy test. Females of non-childbearing potential must be confirmed via post-menopausal status or documentation of irreversible surgical sterilization at the Screening Visit. * Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods. * Have a body mass index between 18 and 32 kg/m2 inclusive and weigh at least 50 kg…
Interventions
- DrugAZD3974
AZD3974 will be administered as an oral solution.
- OtherPlacebo
Placebo will be administered as an oral solution.
Locations (2)
- Research SiteGlendale, California
- Research SiteBaltimore, Maryland