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

Registration

Registration

NCT07013643

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

ACTIVE_NOT_RECRUITING

Enrollment

100

Start

2025-06-04

Primary completion

2027-07-09

Lead sponsor

AstraZeneca

Conditions

Healthy Participants

Interventions

DRUG:AZD6234; DRUG:Ethinyl estradiol/Levonorgestrel (EE/LEVO); DRUG:Acetaminophen (APAP); DRUG:AZD9550

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Area under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVO [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 [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 [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 [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 [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]