Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04991766 | A Study of [¹⁴C]-LY3484356 in Healthy Female Participants | PHASE1 | COMPLETED | 16 | — | — | Aug 13, 2021 | Apr 2, 2022 | Dec 5, 2025 | 1 | United States |
| NCT04840888 | A Study of LY3484356 in Healthy Female Participants | PHASE1 | COMPLETED | 82 | — | — | Apr 26, 2021 | Apr 12, 2022 | Dec 11, 2025 | 2 | United States |
The percentage of the total radioactive dose administered that was excreted in feces = (amount of radioactive dose recovered in feces / total radioactive dose administered) \* 100.
The percentage of the total radioactive dose administered that was excreted in urine = (amount of radioactive dose recovered in urine / total radioactive dose administered) \* 100.
PK: Bioavailability is defined as the percentage of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma LY3484356 as "F %= \[AUC (0-∞), LY3484356\] × \[Dose, \[14C\]-LY3484356\] / \[AUC (0-∞), \[14C\]-LY3484356\] × \[Dose, LY3484356\] ×100%'' Higher percent indicates better absorption of drug into the body.
PK: AUC\[0-∞\] of LY3484356
PK: AUC\[0-∞\] of LY3484356
PK: AUC\[0-∞\] of LY3484356
AUC\[0-∞\] of LY3484356
PK: Tmax of LY3484356
PK: Tmax of LY3484356
PK: Tmax of LY3484356
Tmax of LY3484356
Cmax of LY3484356
Cmax of LY3484356
Cmax of LY3484356
Cmax of LY3484356
| Arm | Type | Description |
|---|---|---|
| [¹⁴C]-LY3484356 (Part 1) | EXPERIMENTAL | Participants received a single oral dose of 400 mg Carbon 14 labelled \[¹⁴C\]-LY3484356 following an overnight fast of at least 10 hours on Day 1. |
| LY3484356 + [¹⁴C]-LY3484356 (Part 2) | EXPERIMENTAL | Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 microgram (μg) \[¹⁴C\]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an intravenous (IV) infusion on day 1. |
| Cohort 1 Sequence 1: 400 mg LY3484356 Fasted/ 400 mg LY3484356 Fed | EXPERIMENTAL | Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 administered as single doses orally with (fed) or without food (fasted) as below: Period 1: Single dose of 400 mg LY3484356 in the fasted state. Period 2: Single dose of 400 mg LY3484356 in the fed state. There was a washout period of 4 days between doses of LY3484356 |
| Cohort 1 Sequence 2: 400 mg LY3484356 Fed/ 400 mg LY3484356 Fasted | EXPERIMENTAL | Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 administered as single doses orally with (fed) or without food (fasted) as below: Period 1: Single dose of 400 mg LY3484356 in the fed state. Period 2: Single dose of 400 mg LY3484356 in the fasted state. There was a washout period of 4 days between doses of LY3484356. |
| Cohort 2: LY3484356 + Omeprazole | EXPERIMENTAL | Participants received single dose of LY3484356 and a single dose of omeprazole alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 5 to 8: 40 mg omeprazole alone once daily Day 9: 400 mg LY3484356 + 40 mg omeprazole once There was a washout period of 8 days between doses of LY3484356. |
| Cohort 3: LY3484356 + Itraconazole | EXPERIMENTAL | Participants received single dose of LY3484356 and a single dose of Itraconazole alone and in combination administered orally as below: Day 1: 200 mg LY3484356 alone Days 5 to 9: 200 mg itraconazole alone (twice on Day 5 \[dose separated by approximately 12 hours\], then once daily on Days 6 through 9) Day 10: 200 mg LY3484356 + 200 mg itraconazole once (coadministered with the morning dose) Days 11 to 16: 200 mg itraconazole alone once daily. There was a washout period of 9 days between doses of LY3484356. |
| Cohort 4: LY3484356 + Carbamazepine | EXPERIMENTAL | Participants received single dose of LY3484356 and a single dose of carbamazepine alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 6 to 8: 100 mg carbamazepine BID alone Days 9 to 11: 200 mg carbamazepine BID alone Days 12 to 17: 300 mg carbamazepine BID alone Day 18: 300 mg carbamazepine BID + 400 mg LY3484356 (coadministered with morning dose) Days 19 to 22: 300 mg carbamazepine BID alone Day 23: 300 mg carbamazepine alone (morning dose only). There was a washout period of 17 days between doses of LY3484356. |
| Cohort 5: Carbamazepine + Midazolam | EXPERIMENTAL | Participants received single dose of Carbamazepine and a single dose of midazolam alone and in combination administered orally as below: Day 1: 1.2 mg midazolam alone Days 2 to 4: 100 mg carbamazepine BID alone Days 5 to 7: 200 mg carbamazepine BID alone Days 8 to 10: 300 mg carbamazepine BID alone Day 11: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose) Days 12 to 13: 300 mg carbamazepine BID alone Day 14: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose). |
| Name | Type | Description |
|---|---|---|
| [¹⁴C]-LY3484356 | DRUG | Administered orally. |
| LY3484356 | DRUG | Administered orally. |
| [¹⁴C]-LY3484356 (IV) | DRUG | Administered IV. |
| Omeprazole | DRUG | Administered orally. |
| Itraconazole | DRUG | Administered orally. |
| Carbamazepine | DRUG | Administered orally. |
| Midazolam | DRUG | Administered orally. |
Inclusion Criteria: * Female participants of nonchildbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization or alternate medical cause/congenital or postmenopausal. * Body mass index (BMI) within the range of 18.0 to 35.0 kil...