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

NCT03315091 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-04-30

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Lone Ottesen, MD · AstraZeneca

  • Henk Verheul, MD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-29
Primary Completion
2018-04-05
Completion
2018-04-05
FDA Drug
Yes

Countries

  • France
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03315091 on ClinicalTrials.gov