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The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a single dose of AZD1775 (printed capsules) in patients with advanced solid tumours.
Full description
This is a Phase I, open-label, randomised, 2-period crossover design study in patients with advanced solid tumours.
The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a single dose of AZD1775 (printed capsules).In addition single dose safety and tolerability data will be gathered.
Patients will be screened within 28 days of Day 1 of the first treatment period (Period 1). Patients will take part in 2 randomised treatment sequences each separated by a washout period of at least 5 and no more than 14 days.
During Period 1, prior to administration of the first dose of study treatment, each patient will be randomised to 1 of 2 treatment sequences (Fasted-Fed or Fed-Fasted) to receive a single oral dose of 300 mg AZD1775 in each of the 2 treatment periods as follows:
Pharmacokinetic and safety assessments will be obtained for up to 72 hours post-dose in each treatment period.
On completion of the study (ie, after collection of 72-hour PK sample and safety in period 2) patients will be evaluated per current assessments for their eligibility and interest to enrol into the open-label continued treatment access study (D6014C000007).
Enrollment
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Inclusion criteria
For inclusion in the study patients should fulfil the following criteria:
where F = 0.85 for females and F = 1 for males
Exclusion criteria
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
Primary purpose
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Interventional model
Masking
31 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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