A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease, Healthy Studies |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 20 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2014 |
| End Date: | February 2016 |
Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3202626
This study involves single and multiple doses of LY3202626 and will evaluate the effects of
LY3202626 on the body. There will be 4 parts to this study. In Parts A and B, single
increasing doses of LY3202626 will be given in capsule form. Part A will also include
itraconazole given orally as a solution. Part A will last approximately 8-12 weeks. Part B
will last approximately 5-6 weeks. In Parts C and D, participants will be dosed multiple
days with the study drug. Part C will last approximately 11-14 weeks. Part D will last
approximately 11-14 weeks and participants must have Alzheimer's Disease. Participants may
only enroll in one part.
LY3202626 on the body. There will be 4 parts to this study. In Parts A and B, single
increasing doses of LY3202626 will be given in capsule form. Part A will also include
itraconazole given orally as a solution. Part A will last approximately 8-12 weeks. Part B
will last approximately 5-6 weeks. In Parts C and D, participants will be dosed multiple
days with the study drug. Part C will last approximately 11-14 weeks. Part D will last
approximately 11-14 weeks and participants must have Alzheimer's Disease. Participants may
only enroll in one part.
Inclusion Criteria:
- For Parts A, B, and C, are overtly healthy males or females (nonchildbearing
potential), as determined by medical history and physical examination
- Have a body mass index (BMI) of 18 to 32 kilograms per square meter (kg/m^2)
- For Part D, present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease
(AD) or mild to moderate AD
- Have venous access sufficient to allow for blood sampling
- Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures and research unit policies
Exclusion Criteria:
- Taking over-the-counter or prescription medication with the exception of vitamins or
minerals
- Smoke more than 10 cigarettes per day
- Are unwilling or unable to refrain from eating any food or drinking any beverage
containing grapefruit or grapefruit juice for at least 2 weeks prior to first dose
until completion of the study
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