The purpose of this study is to assess the impact of multiple doses of itraconazole on the pharmacokinetics (PK) of AZD5004 in healthy participants (Part A), and to assess the impact of multiple doses of AZD5004 on the PK of Combined Oral Contraceptives (COCs) in healthy female participants (Part B).
This study will be an open-label, fixed-sequence, two-part study in healthy participants. There are 2 parts in this study: Part A: performed in healthy male and female participants. Part B: performed in healthy female participants. Part A will consist of: 1. Screening period of 27 days 2. Period 1 3. Period 2 4. Period 3 5. Follow-up period of 17 to 24 days after the last AZD5004 dose Part B will consist of: 1. Screening period of 27 days 2. Start of study period 3. Up-titration period 4. End of study period 5. Follow-up
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
AZD50004 is administered orally as a tablet.
Itraconazole is administered orally as a capsule.
EE/LNG is administered orally in the form of tablet.
Research Site
Baltimore, Maryland, United States
Research Site
Berlin, Germany
Part A: Area under concentration-time curve from time zero to infinity (AUCinf) of AZD5004
To assess the effect of multiple doses of itraconazole on the AUCinf of a single dose of AZD5004 in healthy male and female participants.
Time frame: Day 1 and Day 10
Part A: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD5004
To assess the effect of multiple doses of itraconazole on the AUClast of a single dose of AZD5004 in healthy male and female participants
Time frame: Day 1 and Day 10
Part A: Maximum observed drug concentration (Cmax) of AZD5004
To assess the effect of multiple doses of itraconazole on the Cmax of a single dose of AZD5004 in healthy male and female participants
Time frame: Day 1 and Day 10
Part A: Terminal elimination half-life (t1/2λz) of AZD5004
To assess the effect of multiple doses of itraconazole on the t1/2λz of a single dose of AZD5004 in healthy male and female participants
Time frame: Day 1 and Day 10
Part A: Time to reach maximum observed concentration (tmax) of AZD5004
To assess the effect of multiple doses of itraconazole on the tmax of a single dose of AZD5004 in healthy male and female participants
Time frame: Day 1 and Day 10
Part A: Apparent total body clearance (CL/F) of AZD5004
To assess the effect of multiple doses of itraconazole on the CL/F of a single dose of AZD5004 in healthy male and female participants
Time frame: Day 1 and Day 10
Part A: Apparent volume of distribution based on the terminal phase (Vz) of AZD5004
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To assess the effect of multiple doses of itraconazole on the Vz of a single dose of AZD5004 in healthy male and female participants
Time frame: Day 1 and Day 10
Part B: Area under concentration-time curve from time zero to infinity (AUCinf) of EE/LNG
To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the AUCinf of single doses of combined oral EE/LNG in healthy female participants
Time frame: Day 1, Day 8, Day 50 and Day 78
Part B: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of EE/LNG
To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the AUClast of single doses of combined oral EE/LNG in healthy female participants
Time frame: Day 1, Day 8, Day 50 and Day 78
Part B: Maximum observed drug concentration (Cmax) of EE/LNG
To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the Cmax of single doses of combined oral EE/LNG in healthy female participants
Time frame: Day 1, Day 8, Day 50 and Day 78
Part B: Terminal elimination half-life (t1/2λz) of EE/LNG
To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the t1/2λz of single doses of combined oral EE/LNG in healthy female participants
Time frame: Day 1, Day 8, Day 50 and Day 78
Part B: Time to reach maximum observed concentration (tmax) of EE/LNG
To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the tmax of single doses of combined oral EE/LNG in healthy female participants
Time frame: Day 1, Day 8, Day 50 and Day 78
Part B: Apparent total body clearance (CL/F) of EE/LNG
To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the CL/F of single doses of combined oral EE/LNG in healthy female participants
Time frame: Day 1, Day 8, Day 50 and Day 78
Part B: Apparent volume of distribution based on the terminal phase (Vz) of EE/LNG
To assess the effect of single and multiple oral dosing of AZD5004, at different dose levels of AZD5004, on the Vz of single doses of combined oral EE/LNG in healthy female participants
Time frame: Day 1, Day 8, Day 50 and Day 78
Part A: Number of patients with Adverse Events (AEs)
To assess the safety and tolerability of AZD5004 alone and in combination with itraconazole in healthy male and female participants
Time frame: From Screening (Day -2 to Day -28) to Day 27
Part B: Number of patients with AEs
To assess the safety and tolerability of AZD5004 alone and in combination with combined oral EE/LNG in healthy female participants
Time frame: From Screening (Day -2 to Day -28) to Day 96
Part B: AUCinf of AZD5004
To assess the effect of single and multiple oral doses of AZD5004, at different dose levels of AZD5004, on the AUCinf of single doses of combined oral EE/LNG in healthy female participants.
Time frame: Days 8, Day 50 and Day 78
Part B: AUClast of AZD5004
To assess the effect of single and multiple oral doses of AZD5004, at different dose levels of AZD5004, on the AUClast of single doses of combined oral EE/LNG in healthy female participants
Time frame: Days 8, Day 50 and Day 78
Part B: Cmax of AZD5004
To assess the effect of single and multiple oral doses of AZD5004, at different dose levels of AZD5004, on the Cmax of single doses of combined oral EE/LNG in healthy female participants
Time frame: Day 8, Day 50 and Day 78