An Open-label, Single-sequence Multiple Cohort Study to Assess the Effect of Multiple Doses of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on the Pharmacokinetics of Single Doses of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity
AstraZeneca
Summary
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.
Description
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 3 cohorts, and each cohort will consist of 5 periods which include, Screening, Start, Up-titration, Maintenance, and Follow-up periods.
Eligibility
- Age range
- 35–75 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * 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. o Hormonal contraceptives and estrogen-containing hormonal methods of birth control are not permitted due to potential effect and influence on the results using a CoC assessment. * Females of non-childbearing potential must be confirmed at the Screening Visit. * Have a Body Mass Index (BMI) between…
Interventions
- DrugAZD6234
AZD6234 will be administered as a subcutaneous injection in the abdomen.
- DrugEthinyl estradiol/Levonorgestrel (EE/LEVO)
EE/LEVO will be administered as combined oral tablets.
- DrugAcetaminophen (APAP)
APAP will be administered orally as a solution.
- DrugAZD9550
AZD9550 will be administered as a subcutaneous injection in the abdomen.
Locations (2)
- Research SiteGlendale, California
- Research SiteBrooklyn, Maryland