A Study of AZD3293 (LY3314814) in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/12/2016 |
| Start Date: | January 2016 |
| End Date: | March 2016 |
A Bioequivalence and Food Effect Study in Healthy Subjects Administered 2 Different Tablet Formulations of AZD3293
The purpose of this study is to measure how much of a new tablet formulation of AZD3293 gets
into the blood stream and how long it takes the body to get rid of it, compared to the
current tablet formulation of AZD3293. The effect of a high fat meal on how quickly the body
absorbs the new tablet formulation will also be evaluated. In addition any side effects of
the study drug using both the new and current tablet formulations will be evaluated. The
study will last about 22 days, with screening required within 30 days prior to the start of
the study.
into the blood stream and how long it takes the body to get rid of it, compared to the
current tablet formulation of AZD3293. The effect of a high fat meal on how quickly the body
absorbs the new tablet formulation will also be evaluated. In addition any side effects of
the study drug using both the new and current tablet formulations will be evaluated. The
study will last about 22 days, with screening required within 30 days prior to the start of
the study.
Inclusion Criteria:
- Male participants: Will be sterile (including vasectomy) or agree to use an effective
method of birth control and will not donate sperm during the study and for 3 months
following the last dose of the investigational product
- Female participants: Women not of childbearing potential due to surgical sterilization
or confirmed by medical history or menopause
- Are able to eat a high-fat, high-calorie meal within the defined time limit and abide by
the food restrictions throughout the study
Exclusion Criteria:
- Have a history of or current, significant ophthalmic disease, as determined by the
investigator or ophthalmologist
- Have vitiligo or any other clinically significant disorder of skin pigmentation as
determined by the investigator or dermatologist
- History or presence of gastrointestinal, hepatic or renal disease or any other
condition known to interfere with absorption, distribution, metabolism or excretion
of drugs
- History of previous or ongoing psychiatric disease/condition
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of
the investigator, increases the risks associated with participating in the study, or
have a history of significant dysrhythmias or atrioventricular (AV) block (including
first degree AV block). Participants with history of persistent PR interval greater
than (>)200 milliseconds (msec) will be excluded
- Have prolonged Fridericia-corrected QT interval (QTcF) of >470 msec
- Have a clinically significant abnormal blood pressure or heart rate (supine) as
determined by the investigator
- Have a history of or current cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematological, or neurological disorders capable of
significantly altering the absorption, metabolism, or elimination of drugs
- Are unwilling to comply with the dietary requirements/restrictions during the study
- Evidence of active renal disease (e.g, diabetic renal disease, polycystic kidney
disease) or calculated creatinine clearance <50 milliliters per minute (mL/min)
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