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.
All participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
Females of non-childbearing potential must be confirmed at the Screening Visit.
Have a Body Mass Index (BMI) between 25 and 40 kg/m2, both inclusive and weigh at least 60 kg for Cohorts 1, 2, and 3 and a BMI of > 30 kg/m2 for Cohort 4.
History of any clinically important disease or disorder (gastroparesis, deep vein thrombosis, venous thromboembolism, previous surgery of the upper gastrointestinal tract, cardiovascular disease, neuromuscular or neurogenic disease, severe vitamin D deficiency (cohort 1, cohort 2 and cohort 4), type I or type II diabetes mellitus, glycated hemoglobin (HbA1c) ≥ 6.5% at screening, history of neoplastic disease (cohort 2, cohort 3 and cohort 4), basal calcitonin level >50 ng/L (50 pg/L) at screening (cohort 2, cohort 3 and cohort 4), history of acute or chronic pancreatitis or pancreatic amylase or lipase >2×ULN at screening (cohort 2, cohort 3 and cohort 4), prior history of cholecystectomy or untreated cholelithiasis and personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2) (cohort 2, cohort 3 and cohort 4).
History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically important illness, medical/surgical procedure, or trauma.
Any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis.
Sequential
AZD6234
DrugAZD6234 will be administered as a subcutaneous injection in the abdomen.
Ethinyl estradiol/Levonorgestrel (EE/LEVO)
DrugEE/LEVO will be administered as combined oral tablets.
Acetaminophen (APAP)
DrugAPAP will be administered orally as a solution.
AZD9550
DrugAZD9550 will be administered as a subcutaneous injection in the abdomen.
Area 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.
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.
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 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.
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.
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.
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.
AUClast of AZD6234
To characterize the PK of single and multiple doses of AZD6234.
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