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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT01951599

Run by

AstraZeneca

People needed

35

Starts

2013-10-09

Expected to finish

2014-06-04

Last updated by the study team

2017-03-31

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 1, Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg. 2, Volunteers must be willing to use a condom, unless their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. 3. In addition, volunteers must agree to continue to take similar contraceptive precautions until 4 months after the last dose of AZD9291.

You may not qualify if…

• Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
• Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to dosing.
• History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to AZD9291, its excipients, or drugs with a similar chemical structure or class.

Where it is running

• Research Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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