A Phase I, Two-Part Study in Healthy Volunteers Consisting of a Randomized, Single-blind, Placebo-controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5004 and a Randomized, Open-Label, Two-way Cross-over Study to Compare the Relative Bioavailability of Two Oral Tablet Strengths of AZD5004

Registration

Registration

NCT06555822

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

SINGLE

Status

COMPLETED

Enrollment

31

Start

2024-08-15

Primary completion

2025-03-06

Lead sponsor

AstraZeneca

Conditions

Healthy Participants

Interventions

DRUG:AZD5004; DRUG:Placebo

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [From screening (Day -28) to last follow up visit (Day 120)]
• Part B: Maximum observed plasma (peak) drug concentration (Cmax) of AZD5004 [From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)]
• Part B: Area under the concentration-curve from time zero to the last quantifiable concentration (AUClast) [From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)]
• Part B: Area under concentration-time curve from time 0 to infinity (AUCinf) [From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)]
• Part B: Time to reach maximum observed concentration (tmax) [From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)]