Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olokizumab · 1 trial · 1 indication
Area under the AUC from time zero extrapolated to infinity, calculated by linear up/log down trapezoidal summation. In case of anomalous predose concentration of greater than 5% of Cmax was indicated, the PK parameters for the affected analyte and given subject were excluded from the analyses. Since caffeine is contained in the plethora of foods and beverages, most subjects had predose caffeine concentrations on Day 1 and Day 22 that exceeded 5% of their Maximum plasma concentration (Cmax). Caffeine PK parameter calculations and analyses were performed using concentrations adjusted by subtracting the contribution of the predose caffeine levels at each postdose timepoint using the following equation: Concentration (adjusted) = Concentration (observed) - \[C predose \* exp(-k\*t)\], with 'k' representing the patient-specific elimination rate constant (λz) determined using observed caffeine concentration data on Day 1 and Day 22 and 't' representing the actual time postdose.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration, calculated by linear up/log down trapezoidal summation for S-warfarin (10 mg warfarin contains 5 mg S-warfarin)
Cmax for all cocktail substrates (caffeine, omeprazole, midazolam and S-warfarin), obtained directly from the observed concentration versus time data. In case of anomalous predose concentration of greater than 5% of Cmax was indicated, the PK parameters for the affected analyte and given subject were excluded from the analyses. Since caffeine is contained in the plethora of foods and beverages, most subjects had predose caffeine concentrations on Day 1 and Day 22 that exceeded 5% of their Cmax. Caffeine PK parameter calculations and analyses were performed using concentrations adjusted by subtracting the contribution of the predose caffeine levels at each postdose timepoint using the following equation: Concentration (adjusted) = Concentration (observed) - \[C predose \* exp(-k\*t)\], with 'k' representing the patient-specific elimination rate constant (λz) determined using observed caffeine concentration data on Day 1 and Day 22 and 't' representing the actual time postdose.
| Arm | Type | Description |
|---|---|---|
| Olokizumab 128 mg +Cocktail drugs | EXPERIMENTAL | All subjects have received the following treatment: Cocktail drugs (Omeprazole + Caffeine + Warfarin (+ vitamin K solution) + Midazolam) orally administered with 240 mL of water on Day 1, single subcutaneous injection of Olokizumab 128 mg administered on Day 8 and second dose of Cocktail drugs (Omeprazole + Caffeine + Warfarin (+ vitamin K solution) + Midazolam) orally administered on Day 22 |
| Name | Type | Description |
|---|---|---|
| Olokizumab | DRUG | Sterile solution for subcutaneous (SC) injection, 128 mg (0.8 mL injection) |
| Omeprazole | DRUG | Tablets, 20 mg, oral |
| Caffeine | DRUG | Tablets, 100 mg, oral |
| Warfarin+ Vitamin K | DRUG | Warfarin -Tablets 10 mg (containing 5 mg S-warfarin), oral. Vitamin K - solution for intravenous injection, 10 mg/mL ampoule, orally. |
| Midazolam | DRUG | Syrup, 2 mg/mL, oral |
Inclusion Criteria: 1. Subjects willing and able to give voluntary informed consent and sign an Informed Consent Form (ICF) 2. Male subjects and their female partners and female subjects of childbearing potential must agree to adhere to the contraceptive requirements for the study Female subjec...
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Olokizumab is an investigational small molecule being developed for the treatment of Rheumatoid Arthritis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. One clinical trial has been completed to evaluate its effects in subjects with this condition.
Olokizumab is being developed by Thermo Fisher Scientific Inc, which trades under the ticker TMO. The company is conducting clinical research on this investigational small molecule for Rheumatoid Arthritis, with the drug currently in Phase 1 development.
Olokizumab is in Phase 1 clinical development for Rheumatoid Arthritis. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.
Olokizumab has one completed clinical trial, NCT04246762, titled 'Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4'. This Phase 1 study enrolled 17 participants in Bulgaria and Moldova.
No alternative names for Olokizumab have been reported. The drug is identified solely by this name in clinical development records. It is an investigational small molecule being studied for Rheumatoid Arthritis by Thermo Fisher Scientific Inc.