NCT03315091

Phase I Study to Assess the Effect of Food on AZD1775 Pharmacokinetics in Patients With Advanced Solid Tumours

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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: * 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).

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	Treatment A - AZD1775 administered under fasted conditions	Premedication with Kytril (granisetron) 1 mg intravenously or Zofran (ondansetron) 8 mg intravenously within 30 to 40 minutes prior to administration of the AZD1775 capsules. Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules) administered orally under fasted conditions. The drug class of AZD1775 is Wee-1 kinase inhibitor.
DRUG	Treatment B - AZD1775 administered under fed conditions.	Premedication with Kytril (granisetron) 1 mg intravenously or Zofran (ondansetron) 8 mg intravenously within 30 to 40 minutes prior to administration of the AZD1775 capsules. Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules) administered orally under fed conditions. The drug class of AZD1775 is Wee-1 kinase inhibitor.

Timeline

• Start date: 2017-09-29
• Primary completion: 2018-04-05
• Completion: 2018-04-05
• First posted: 2017-10-19
• Last updated: 2018-04-30

Locations

7 sites across 3 countries: France, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study