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To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.

NCT01951599 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-03-31

No results posted yet for this study

Summary

To determine the relative bioavailability of different oral formulations of AZD9291 and the effect of food in healthy volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AZD9291

Volunteers will receive a single 20-mg dose of AZD9291 as a capsule on day 1, in Part A, Period 1, in the fasted state. (Treatment A).

DRUG

AZD9291

Volunteers will receive a single 20-mg dose of AZD9291 as a solution on day 1, in Part A, Period 2, in the fasted state. (Treatment B).

DRUG

AZD9291

Volunteers will receive a single 20-mg dose of AZD9291 as a tablet on day 1, in Part A, Period 3, in the fasted state. (Treatment C).

DRUG

AZD9291

Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 1, in the fasted state.

DRUG

AZD9291

Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 2, in the fed state.

Sponsors & Collaborators

Principal Investigators

  • Phil Leese, MD · Quintiles 6700 W 115th Street, Kansas, US

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-09
Primary Completion
2014-06-04
Completion
2014-06-04

Countries

  • United States

Study Locations

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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 NCT01951599 on ClinicalTrials.gov