Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Drug Cocktail · 3 trials · 2 indications
PK: Area Under the Concentration Curve (AUC) Time Zero to Infinity (AUC \[0-∞\]) of Midazolam
PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Warfarin
PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Dextromethorphan
PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Omeprazole
PK: AUC Time Zero to Infinity (AUC\[0-∞\]) of Caffeine
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Midazolam)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Warfarin)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Warfarin)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Dextromethorphan)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Caffeine)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to 48 hours (AUC\[0-48h\]) of CYP450 Substrate (Caffeine)
Maximum concentration of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Maximum concentration of S-warfarin after single dose of drug cocktail on Day 1 in Period 1and in combination with Abemaciclib on Day 8 in Period 2.
Maximum concentration of dextromethorphan after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Maximum concentration of midazolam after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
PK: AUC zero to infinity of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
AUC (zero to infinity) of S-warfarin after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
PK: AUC (zero to infinity) of dextromethorphan after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
PK: AUC (zero to infinity) of midazolam after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
| Arm | Type | Description |
|---|---|---|
| Drug Cocktail | EXPERIMENTAL | Period 1: Participants received a single dose of the following drug cocktail on Day 1: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg Caffeine administered orally |
| Mirikizumab + Drug Cocktail | EXPERIMENTAL | Period 2: Participants received 250 mg mirikizumab subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks (Days 1 to Day 113) Period 2: Participants received the second dose of the drug cocktail: 1 mg midazolam, 10 mg warfarin, 10 mg vitamin K, 30 mg dextromethorphan, 20 mg omeprazole, 100 mg caffeine administered orally on Day 116. |
| Drug Cocktail + Ixekizumab | EXPERIMENTAL | Drug cocktail (caffeine, warfarin \[plus vitamin K\], omeprazole, dextromethorphan, and midazolam) administered orally twice in Period 2 (day 8 and day 85). Ixekizumab administered subcutaneously (SC) on multiple occasions in Period 2. |
| Drug Cocktail - Period 1 | ACTIVE_COMPARATOR | Single dose of drug cocktail: 100 milligram (mg) caffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1. |
| 200 mg Abemaciclib + Drug Cocktail - Period 2 | EXPERIMENTAL | 200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 - 12 in Period 2 with a single dose of drug cocktail: 100 mgcaffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2. |
| 200 mg Abemaciclib - Period 3 | EXPERIMENTAL | 200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3. Participants may continue to receive abemaciclib until discontinuation criteria are met. |
| 200 mg Abemaciclib - Period 4 | EXPERIMENTAL | 200 mg Abemaciclib administered orally Q12H on Days 1 to 28 in Period 4. Participants may continue to receive abemaciclib until discontinuation criteria are met. |
| Safety Extension Period | EXPERIMENTAL | 200 mg Abemaciclib administered orally Q12H on Days 1 to 28 onwards in extension period. Participants may continue to receive abemaciclib until discontinuation criteria are met. |
| Name | Type | Description |
|---|---|---|
| Drug Cocktail | DRUG | Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally |
| Mirikizumab | DRUG | Administered SC |
| Ixekizumab | DRUG | Administered SC |
| Abemaciclib | DRUG | Administered orally |
Inclusion Criteria: * Males and females with chronic plaque psoriasis for at least 6 months who are candidates for systemic therapy or phototherapy * Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at screening and first admission to the clinical site Exclusion Cri...
Drug Cocktail is an investigational small molecule being developed by Eli Lilly and Company for Neoplasm Metastasis and Psoriasis. It is currently in Phase 1 clinical development, with completed trials studying its use in these conditions.
Drug Cocktail is being developed by Eli Lilly and Company, a biopharmaceutical company listed on the stock exchange under the ticker LLY. The drug is currently in Phase 1 clinical trials for oncology and dermatology indications.
Drug Cocktail is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for safety and efficacy.
Drug Cocktail has been studied in three completed Phase 1 trials: NCT02688088 for Neoplasm Metastasis, NCT02993471 for Psoriasis, and NCT03718884 for Psoriasis. These trials were conducted in the United States with adult participants.
Drug Cocktail is not the same as abemaciclib, ixekizumab, or mirikizumab. The clinical trials listed under Drug Cocktail include studies of these individual drugs, but Drug Cocktail itself is a separate investigational product developed by Eli Lilly and Company.