Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3202626 · 3 trials · 3 indications
Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626
PK is the area under the concentration versus time curve from time zero to infinity (AUC\[0-∞\]) of LY3202626
PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3202626
Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered
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 |
|---|---|---|
| LY3202626 (R-Fasting) | EXPERIMENTAL | Single oral dose of LY3202626 (R) capsule under fasting conditions. |
| LY3202626 (T1-Fasting) | EXPERIMENTAL | Single oral dose of LY3202626 (T1) tablet under fasting conditions. |
| LY3202626 (T1-Fed) | EXPERIMENTAL | Single oral dose of LY3202626 (T1) following a high fat breakfast. |
| [¹⁴C]-LY3202626 | EXPERIMENTAL | Single oral dose of LY3202626 containing 100 micro curies of radioactivity |
| 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 (R-Fasting) | DRUG | Administered orally |
| LY3202626 (T1-Fasting) | DRUG | Administered orally |
| LY3202626 (T1-Fed) | DRUG | Administered orally |
| [¹⁴C]-LY3202626 | DRUG | Administered as solution by mouth |
| LY3202626 | DRUG | administered orally |
| Placebo (Part A, B, C) | DRUG | administered orally |
| Itraconazole | DRUG | administered orally |
Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination * Female participants must be of non-childbearing potential confirmed by medical history or menopause * Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/...
LY3202626 is an investigational small molecule being studied in healthy volunteers and in participants with Alzheimer's disease. It is being developed by Eli Lilly and Company. The drug is in Phase 1 clinical development, meaning it is still being tested in early-stage trials and is not yet approved for any use.
LY3202626 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical trials, which are being conducted in the United States and Singapore.
LY3202626 is in Phase 1 clinical development. All clinical trials for this drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities for any indication.
LY3202626 has been studied in three completed Phase 1 clinical trials. NCT02323334 evaluated the drug in healthy participants and participants with Alzheimer's disease in the United States. NCT02555449 studied a radiolabeled form in healthy male participants, and NCT03023826 assessed the drug in healthy participants in Singapore.
LY3202626 is the primary name for this investigational drug. No alternative names have been disclosed in the clinical trial records. The drug is being developed by Eli Lilly and Company and is currently in Phase 1 clinical development for healthy volunteers and Alzheimer's disease.