To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 4/1/2017 |
Start Date: | October 9, 2013 |
End Date: | June 4, 2014 |
A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food
To determine the relative bioavailability of different oral formulations of AZD9291 and the
effect of food in healthy volunteers.
effect of food in healthy volunteers.
A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to
Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the
Effect of Food
Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the
Effect of Food
Inclusion Criteria:
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.
Exclusion Criteria:
1. Any clinically relevant abnormalities in physical examination, vital signs,
hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the
Investigator.
2. Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to
dosing.
3. 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.
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