This study will be conducted in healthy post-menopausal female subjects to assess the pharmacokinetics (PK) of Camizestrant (AZD9833) when administered alone and in combination with Itraconazole.
This open-label, fixed sequence study will comprise of: * A screening period of 28 days; * A fixed sequence of three treatment period: Treatment Period 1: Camizestrant only, Treatment Period 2: Itraconazole only, Treatment Period 3: Camizestrant and Itraconazole in combination. • A Follow-up Visit at 7 to 14 days after the last Camizestrant PK sample in Period 3. There will be a washout period of 7 to 10 days between Period 1 and Period 2. Each subject will be involved in the study for approximately 8 or 9 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
14
Subjects will be administered a single oral dose of Camizestrant on Day 1 of treatment period 1 and treatment period 3.
Subjects will be administered Itraconazole twice a day on Day 1 and once daily on Day 2 and Day 3 of treatment period 2, and once daily on Day 1, 2 and 3 of treatment period 3.
Research Site
Harrow, United Kingdom
Area under plasma concentration time curve from zero to infinity (AUCinf) of Camizestrant
To assess the effect of Itraconazole on AUCinf of Camizestrant.
Time frame: Day 1 to Day 4 (Period 1 and Period 3)
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of Camizestrant
To assess the effect of Itraconazole on AUClast of Camizestrant.
Time frame: Day 1 to Day 4 (Period 1 and Period 3)
Maximum observed plasma (peak) drug concentration (Cmax) of Camizestrant
To assess the effect of Itraconazole on Cmax of Camizestrant.
Time frame: Day 1 to Day 4 (Period 1 and Period 3)
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Safety and tolerability of Camizestrant alone and in combination with Itraconazole will be assessed.
Time frame: From Screening (Day -28 to Day -2) up to follow-up visit (7 to 14 days after last Pharmacokinetic Sample) [approximately 9 weeks]
Number of subjects with adverse events leading to the discontinuation of study drug (DAEs)
Number of subjects who discontinue the study drug due to adverse events will be assessed.
Time frame: From Day 1 (period 1) up to follow-up visit (7 to 14 days after last Pharmacokinetic Sample) [approximately 9 weeks]
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.