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Also known as LY3202626 (R-Fasting), [¹⁴C]-LY3202626
LY3202626 · 1 trial · 2 indications
A summary of other nonserious Adverse Events (AE's), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| Arm | Type | Description |
|---|---|---|
| Part A Cohort 1 Sequence1: 0.1mg, 1.6mg, Placcebo; 15mg | PLACEBO_COMPARATOR | Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: 0.1mg LY3202626 Period 2: 1.6mg LY3202626 Period 3: 15 mg placebo (PBO) Period 4: 15mg LY3202626. |
| Part A Cohort 1 Sequence 2: 0.1mg, PBO, 15mg, 15mg | EXPERIMENTAL | Part A Cohort 1 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: 0.1mg Period 2: PBO Period 3: 15mg LY3202626 Period 4: 15mg LY3202626. |
| Part A Cohort 1 Sequence 3: PBO, 1.6mg, 15mg, Placebo | EXPERIMENTAL | Part A Cohort 1 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: PBO Period 2: 1.6mg LY3202626 Period 3: 15mg LY3202626 Period 4: PBO. |
| Part A Cohort 2 Sequence 1:0.4mg, 5mg, PBO, 0.4mg/Itraconazole | EXPERIMENTAL | Part A Cohort 2 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: 0.4mg LY3202626 Period 2: 5mg LY3202626 Period 3: 45mg, PBO Period 4: 0.4mg LY3202626/200mg Itraconazole. |
| Part A Cohort 2 Sequence 2: 0.4mg, PBO, 45mg. 0.4mg/Itra | EXPERIMENTAL | Part A Cohort 2 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: 0.4mg LY3202626 Period 2: 5mg, PBO Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole. |
| Part A Cohort 2 Sequence 3:PBO, 5mg, 45mg,0.4mg/200mg Itra | EXPERIMENTAL | Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: 0.4mg, PBO Period 2: 5mg LY3202626 Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole. |
| Part A Cohort 3 Sequence 1: Food Effect Fed/Fasted | EXPERIMENTAL | Part A Cohort 3 involved healthy participants and was comprised of two treatment periods with a washout period of approximately 14 days between doses. Single dose of 10mg LY3202626 given PO in Period 1 and 2. Period 1: Fed 2: Fasted. |
| Part A Cohort 3 Sequence 2: Food Effect Fasted/Fed | EXPERIMENTAL | Part A Cohort 3 involved healthy participants and was comprised of two treatment periods with a washout period of approximately 14 days between doses. Single dose 10mg LY3202626 given PO in Period 1 and 2. Period 1: Fasted 2: Fed. |
| Part B Cohort 4: 1.6mg | EXPERIMENTAL | Part B Cohort 4 involved healthy participants and was comprised of one period. Single dose of 1.6mg LY3202626 given PO in Period 1. Dose determined by Part A. |
| Part B Cohort 5: 10mg | EXPERIMENTAL | Part B Cohort 5 involved healthy participants and was comprised of one period. Single dose of 10mg LY3202626 given PO in Period 1. Dose determined by Part A. |
| Part B Cohort 6: 26mg | EXPERIMENTAL | Part B Cohort 6 involved healthy participants and was comprised of one period. Single dose of 26mg LY3202626 given PO in Period 1. Dose determined by Part A. |
| Part B Cohort 4, 5, 6: Placebo Comparator | PLACEBO_COMPARATOR | Part B Cohort 4,5,6 involved healthy participants and was comprised of one period. Single dose of PBO given PO in Period 1. |
| Part C Cohort 7: 1mg | EXPERIMENTAL | Part C Cohort 7 involved healthy participants and was comprised of one period. 1mg LY3202626 given PO once daily for 14 days. Dose determined by Part B. |
| Part C Cohort 8: 6mg | EXPERIMENTAL | Part C Cohort 8 involved healthy participants and was comprised of one period. 6mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B. |
| Part C Cohort 9: 26mg | EXPERIMENTAL | Part C Cohort 9 included healthy participants and was comprised of one period. 26mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B. |
| Part C Cohort 7, 8 ,9: Placebo Comparator | PLACEBO_COMPARATOR | Part C Cohort 7,8,9 involved healthy participants and was comprised of one period. Placebo given PO once daily for 14 days. |
| Part D Cohort 10: 6mg | EXPERIMENTAL | Part D Cohort 10 involved participants with Alzheimer's disease and was comprised of one period. 6mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B. |
| Name | Type | Description |
|---|---|---|
| LY3202626 | DRUG | administered orally |
| Placebo (Part A, B, C) | DRUG | administered orally |
| Itraconazole | DRUG | administered orally |
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 Impairme...
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LY3202626 is an investigational small molecule developed by Eli Lilly and Company for Alzheimer disease. It has been studied in a Phase 1 clinical trial that enrolled 94 participants, including healthy volunteers and people with Alzheimer disease. The trial was completed, and the drug is not approved for any indication.
LY3202626 was being studied for the treatment of Alzheimer disease. It is an investigational therapy and has not been approved for any use. The only clinical trial of LY3202626 enrolled participants with Alzheimer disease and healthy volunteers to evaluate the drug in a Phase 1 setting.
LY3202626 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Eli Lilly sponsored the Phase 1 trial of LY3202626 in healthy participants and participants with Alzheimer disease.
LY3202626 is in Phase 1 development. It has completed one Phase 1 clinical trial and has no active trials. The drug remains investigational and has not received FDA approval for any indication.
LY3202626 has been studied in one completed Phase 1 trial, NCT02323334, titled "A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease." The trial enrolled 94 participants in the United States, was randomized, double-blind, and placebo-controlled, and included both healthy volunteers and participants with Alzheimer disease.
Yes, LY3202626 (R-Fasting) and [¹⁴C]-LY3202626 are alternative names for LY3202626. These names refer to the same investigational small molecule developed by Eli Lilly and Company for Alzheimer disease.