A study to demonstrate pharmacokinetics of AZD4831 when administered alone and in combination with Itraconazole.
This will be a an open-label, 3-period fixed sequence study to be conducted at a single study centre. The treatment starts with AZD4831 (Treatment Period 1), followed by Itraconazole administration for 3 days (Treatment Period 2) and finally a combination of AZD4831+Itraconazole administration (Treatment Period 3). The study will comprise of: * A Screening Period of approximately 28 days. * Three Treatment Periods: * Treatment Period 1 (Day -1 through pre-dose Day 8): Single oral dose of AZD4831 only on Day 1, * Treatment Period 2 (Day 8 through pre-dose Day 11): Oral dose of Itraconazole only on Days 8 through 10, * Treatment Period 3 (Day 11 through Day 18, after the last PK sample is collected): AZD4831 and Itraconazole on Day 11 and oral dosing of Itraconazole only on Days 12 through 17. * A final Follow-up Visit after the last PK sample (Day 25 to Day 32). Each subject will be involved in the study for approximately 9 weeks (including the 28 day Screening Period).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Subjects will receive single oral dose only on Day 1 and Day 11.
Subjects will receive Itraconazole orally on Days 8 followed by dosing from Day 9 to Day 17.
Research Site
Harrow, United Kingdom
Maximum observed plasma (peak) drug concentration (Cmax) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Area under plasma concentration time curve from zero to infinity (AUCinf) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Time to reach peak or maximum observed concentration or response following drug administration (tmax) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t½λz) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase (Vz/F) for AZD4831
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To assess the effect of Itraconazole on AZD4831 only.
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Terminal elimination rate constant (λz) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Number of subjects with adverse events (AE)
To assess safety and tolerability of AZD4831 alone and in combination with Itraconazole.
Time frame: From Screening (Day -28 to Day -2) to Follow-up visit (Between Day 25 and Day 32)