LivingGLP1
Study S003360

An Open-label, Fixed-sequence and Two-part Study to Assess the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on the Pharmacokinetics of Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants

ClinicalTrials.gov record

Registration

Registration
NCT06942936
Study type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Phase
PHASE1
Masking
NONE
Status
COMPLETED
Enrollment
51
Start
2025-05-28
Primary completion
2026-01-28
Lead sponsor
AstraZeneca
Conditions
Healthy Participants
Interventions
DRUG:AZD5004; DRUG:Itraconazole; DRUG:EE/LNG
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:2024-518467-35-00

Registered primary outcomes

  • Part A: Area under concentration-time curve from time zero to infinity (AUCinf) of AZD5004 [Day 1 and Day 10]
  • Part A: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD5004 [Day 1 and Day 10]
  • Part A: Maximum observed drug concentration (Cmax) of AZD5004 [Day 1 and Day 10]
  • Part A: Terminal elimination half-life (t1/2λz) of AZD5004 [Day 1 and Day 10]
  • Part A: Time to reach maximum observed concentration (tmax) of AZD5004 [Day 1 and Day 10]
  • Part A: Apparent total body clearance (CL/F) of AZD5004 [Day 1 and Day 10]
  • Part A: Apparent volume of distribution based on the terminal phase (Vz) of AZD5004 [Day 1 and Day 10]
  • Part B: Area under concentration-time curve from time zero to infinity (AUCinf) of EE/LNG [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 [Day 1, Day 8, Day 50 and Day 78]
  • Part B: Maximum observed drug concentration (Cmax) of EE/LNG [Day 1, Day 8, Day 50 and Day 78]
  • Part B: Terminal elimination half-life (t1/2λz) of EE/LNG [Day 1, Day 8, Day 50 and Day 78]
  • Part B: Time to reach maximum observed concentration (tmax) of EE/LNG [Day 1, Day 8, Day 50 and Day 78]
  • Part B: Apparent total body clearance (CL/F) of EE/LNG [Day 1, Day 8, Day 50 and Day 78]
  • Part B: Apparent volume of distribution based on the terminal phase (Vz) of EE/LNG [Day 1, Day 8, Day 50 and Day 78]

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