MedTrace Logo

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

NCT01895946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2016-05-25

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Advanced Solid Malignancy,
  • Safety and Tolerability,
  • Pharmacokinetics, Pharmacodynamics,
  • Tumour Response,

Interventions

DRUG

AZD5363

Oral AZD5363 twice daily, 4 days on 3 days off: tablet formulation for one week, followed by two weeks with capsule formulation.

DRUG

AZD5363

Oral AZD5363 twice daily, 4 days on 3 days off, tablet formulation. On day 4 AZD5363 tablet without food. On day 11 AZD5363 tablet with food.

Sponsors & Collaborators

Principal Investigators

  • Justin Lindemann, MSD · AstraZeneca

  • Udai Banerji, MD, PhD · Institute of Cancer Research, United Kingdom

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-02-28
Completion
2015-07-31

Countries

  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01895946 on ClinicalTrials.gov