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Spots Global Cancer Trial Database for Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

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Trial Identification

Brief Title: Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

Official Title: A Phase I, Open-Label, Multicentre Study to Compare Two Dosage Formulations of AZD5363 and to Establish the Effect of Food on the Pharmacokinetic Exposure, Safety and Tolerability of AZD5363 in Patients With Advanced Solid Malignancies

Study ID: NCT01895946

Interventions

AZD5363
AZD5363

Study Description

Brief Summary: Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

Detailed Description: This study is designed to investigate the safety, tolerability and pharmacokinetics of a new drug, AZD5363, in patients with advanced cancer . This study will investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug), the comparison of a capsule and a tablet formulation and the effect of food on AZD5363 tablet formulation.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Research Site, Amsterdam, , Netherlands

Research Site, Manchester, , United Kingdom

Research Site, Surrey, , United Kingdom

Contact Details

Name: Justin Lindemann, MSD

Affiliation: AstraZeneca

Role: STUDY_DIRECTOR

Name: Udai Banerji, MD, PhD

Affiliation: Institute of Cancer Research, United Kingdom

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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