The purpose of this study is to assess the relative bioavailability of a single dose AZD5004 in healthy participants, among 3 different oral tablet formulations.
This study will be an open-label, randomized, 4-period, 4-treatment, single-dose crossover study in healthy participants. Participants will receive one single dose of AZD5004 at the beginning of each of the four Treatment Periods, and a total of 4 doses of AZD5004. Three different formulations (F1, F3, and F4) will be used across the Treatment Periods. The study comprises of total four treatment periods. * A Screening Period of maximum 27 days. Four Treatment Periods of 7 days each. * Treatment Period 1 (Day -1 to Day 6) * Treatment Period 2 (Day 7 to Day 13) * Treatment Period 3 (Day 14 to Day 20) * Treatment Period 4 (Day 21 to Day 27) * A final Follow-up Visit within 7 to 10 days after the last study intervention administration (Day 22 of Treatment Period 4). The treatments are as follows: * Treatment 1: Single dose of AZD5004 in Formulation 1 (F1) -fasted * Treatment 2: Single dose of AZD5004 in Formulation 4 (F4) -fasted * Treatment 3: Single dose of AZD5004 in F4- fed * Treatment 4: Single dose of AZD5004 in Formulation 3 (F3) - fasted Participants will be randomized equally to one of the following treatment sequences: * Treatment Sequence A: F1, F4, F4 (fed), F3 * Treatment Sequence B: F4, F4 (fed), F3, F1 * Treatment Sequence C: F4 (fed), F3, F1, F4 * Treatment Sequence D: F3, F1, F4, F4 (fed)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Participants will be receiving three different formulations (F1, F3, and F4) as single dose of AZD5004 orally in fasted and fed state.
Research Site
Baltimore, Maryland, United States
Area under concentration-time curve from time 0 to infinity (AUCinf)
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Maximum observed drug concentration (Cmax)
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Time to reach maximum observed concentration (tmax)
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Half-life (t½)
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Apparent total body clearance (CL/F)
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Area under concentration-time curve from time 0 to infinity (AUCinf)
To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)
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Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)
Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Maximum observed drug concentration (Cmax)
To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)
Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Time to reach maximum observed concentration (tmax)
To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)
Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Half-life (t½)
To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)
Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Apparent total body clearance (CL/F)
To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)
Time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To study the safety and tolerability of a single dose AZD5004 in 3 different solid oral formulations (F1, F3, F4), and F4 under fasted and fed conditions in healthy participants
Time frame: Screening (Day -28 to Day -2) up to Follow-up (Day 29 to Day 32)