Solid Tumours Clinical Trial
Official title:
A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of AZD1775 After Oral Dosing of a Capsule Formulation 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 patients with advanced solid tumours.
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:
- Fasted (Treatment A): Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules).
- Fed (Treatment B): Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules).
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).
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