This study will measure the effects of multiple doses of AZD6234, AZD9550 and a combination of AZD9550 and AZD6234 given as injection(s) on pharmacokinetics (PK) of combined oral contraceptive (CoC) ethinyl estradiol (EE)/levonorgestrel (LEVO) in healthy female participants with obesity.
This is a Phase I, open-label, single-sequence, multiple-cohort study which will be performed at multiple study sites in healthy females of childbearing and non-childbearing potential. The purpose of this study is to investigate the effect of AZD6234, AZD9550 and a combination of AZD9550 and AZD6234 on the PK, safety and tolerability of a CoC, ethinyl estradiol/levonorgestrel (EE/LEVO). The study will have 4 cohorts, and each cohort will consist of 5 periods which include, Screening, Start, Up-titration, Maintenance, and Follow-up periods.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
AZD6234 will be administered as a subcutaneous injection in the abdomen.
EE/LEVO will be administered as combined oral tablets.
APAP will be administered orally as a solution.
AZD9550 will be administered as a subcutaneous injection in the abdomen.
Research Site
Glendale, California, United States
RECRUITINGResearch Site
Brooklyn, Maryland, United States
RECRUITINGArea under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVO
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
Time frame: Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253
Area under the concentration-time curve from time of dosing to the last measurable concentration (AUClast) of EE and LEVO
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
Time frame: Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253
Maximum plasma concentration (Cmax) of EE and LEVO
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
Time frame: Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253
Time to reach maximum drug concentration in plasma (tmax) of EE and LEVO
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
Time frame: Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253
Elimination half-life (t1/2λz) of EE and LEVO
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
Time frame: Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253
Number of participants with adverse events (AEs)
To assess the safety and tolerability of AZD6234, co-administered AZD9550 and AZD6234, and AZD9550 with CoC EE/LEVO.
Time frame: Cohort 1: Up to Day 120; Cohort 2: Up to Day 216; Cohort 3: Up to Day 272; Cohort 4: Up to Day 300
Number of participants developing detectable anti-drug antibodies (ADAs) against AZD6234 and AZD9550
To assess the immunogenicity of AZD6234, co-administered AZD9550 and AZD6234, and AZD9550 with CoC EE/LEVO.
Time frame: Cohort 1: At predefined intervals from Day -2 up to Day 120; Cohort 2: At predefined intervals from Day -2 up to Day 216; Cohort 3: At predefined intervals from Day -2 up to Day 272; ; Cohort 4: At predefined intervals from Day -2 up to Day 300
Area under plasma concentration-time curve from time 0 to 168 hours postdose (AUC0-168h) of AZD6234
To characterize the PK of single and multiple doses of AZD6234.
Time frame: Cohort 1: At predefined intervals from Day 1 to Day 120
AUClast of AZD6234
To characterize the PK of single and multiple doses of AZD6234.
Time frame: Cohort 1: At predefined intervals from Day 1 to Day 120
Cmax of AZD6234
To characterize the PK of single and multiple doses of AZD6234.
Time frame: Cohort 1: At predefined intervals from Day 1 to Day 120
AUC0-168h of co-administered AZD6234 and AZD9550
To characterize the PK of single and multiple doses of co-administered AZD6234 and AZD9550.
Time frame: Cohort 2: At predefined intervals from Day 8 to Day 216; Cohort 4: At predefined intervals from Day 78 to Day 300
AUClast of co-administered AZD6234 and AZD9550
To characterize the PK of single and multiple doses of co-administered AZD6234 and AZD9550.
AstraZeneca Clinical Study Information Center
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Cohort 2: At predefined intervals from Day 8 to Day 216; Cohort 4: At predefined intervals from Day 78 to Day 300
Cmax of co-administered AZD6234 and AZD9550
To characterize the PK of single and multiple doses of co-administered AZD6234 and AZD9550.
Time frame: Cohort 2: At predefined intervals from Day 8 to Day 216; Cohort 4: At predefined intervals from Day 78 to Day 300
AUC0-168h of AZD9550
To characterize the PK of single and multiple doses of AZD9550.
Time frame: Cohort 3: At predefined intervals from Day 8 up to Day 272
AUClast of AZD9550
To characterize the PK of single and multiple doses of AZD9550.
Time frame: Cohort 3: At predefined intervals from Day 8 up to Day 272
Cmax of AZD9550
To characterize the PK of single and multiple doses of AZD9550.
Time frame: Cohort 3: At predefined intervals from Day 8 up to Day 272