Phase 1
Completed N=94
A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease
Healthy Volunteers · Alzheimer's Disease
Source: ClinicalTrials.gov NCT02323334 ↗
Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3202626 |
0.169; 0.486; 2.89; 7.91; 21.3; 92.5 | — |
| SECONDARY PK: Area Under the Concentration Time Curve (AUC) of LY3202626 |
NA; NA; 60.6; 197; 393; 1680 | — |
| SECONDARY Pharmacodynamic(PD) Biomarker: Plasma Minimum Amyloid-Beta Peptide (A-beta) 1-40 Concentration |
107; 58.1; 61.8; 33.4; 25.2; 17.0 | — |
| SECONDARY PD Biomarker: Cerebral Spinal Fluid (CSF) Minimum Amyloid-beta Peptide (A-beta) 1-40 Concentration |
7980; 5700; 5770; 2980 | — |
| SECONDARY PK: CSF Concentration of LY3202626 |
0.0648; 0.202; 1.26 | — |
| SECONDARY PD Biomarker: Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid-beta Peptide (A-beta) 1-40 Concentration |
-21.3; -50.1; -75.7; -93.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02323334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.