Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Caffeine · 2 trials · 3 indications
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. Due to dietary caffeine intake may resulted in positive pre-dose concentrations, absolute and/or baseline-adjusted caffeine were analyzed. Baseline adjusted concentration = measured concentration - \[predose concentration\*e\^(-Kel\*t)\], where Kel is terminal elimination rate constant based on actual measured concentration values for each profile and t is the actual sampling time.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. Due to dietary caffeine intake may resulted in positive pre-dose concentrations, absolute and/or baseline-adjusted caffeine were analyzed. Baseline adjusted concentration = measured concentration - \[predose concentration\*e\^(-Kel\*t)\], where Kel is terminal elimination rate constant based on actual measured concentration values for each profile and t is the actual sampling time.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. Paraxanthine was the metabolite of caffeine.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. 5-OH Omeprazole was the metabolite of omeprazole.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. Hydroxybupropion was the metabolite of bupropion.
AUClast is area under the concentration-time profile (AUC) from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. The metabolites of midazolam included total 1-OH midazolam, free 1-OH midazolam, and glucuronide conjugated 1-hydroxymidazolam.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. Due to dietary caffeine intake may resulted in positive pre-dose concentrations, absolute and/or baseline-adjusted caffeine were analyzed. Baseline adjusted concentration = measured concentration - \[predose concentration\*e\^(-Kel\*t)\], where Kel is terminal elimination rate constant based on actual measured concentration values for each profile and t is the actual sampling time.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. Due to dietary caffeine intake may resulted in positive pre-dose concentrations, absolute and/or baseline-adjusted caffeine were analyzed. Baseline adjusted concentration = measured concentration - \[predose concentration\*e\^(-Kel\*t)\], where Kel is terminal elimination rate constant based on actual measured concentration values for each profile and t is the actual sampling time.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. Paraxanthine was the metabolite of caffeine.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. 5-OH Omeprazole was the metabolite of omeprazole.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. Hydroxybupropion was the metabolite of bupropion.
Ae0-8 is the amount excreted into the urine over the collection interval of 0 to 8 hours.
Ae0-8 is the amount excreted into the urine over the collection interval of 0 to 8 hours. E-3174 was the metabolite of losartan.
Ae0-8 is the amount excreted into the urine over the collection interval of 0 to 8 hours.
Ae0-8 is the amount excreted into the urine over the collection interval of 0 to 8 hours. Dextrorphan was the metabolite of dextromethorphan.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data.
Cmax is the maximum plasma concentration which was observed directly from the concentration-time data. LHY746 was the metabolite of encorafenib.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method.
AUClast is AUC from time 0 to the time of the last quantifiable concentration. It was calculated using the linear trapezoidal/linear interpolation method. LHY746 was the metabolite of encorafenib.
| Arm | Type | Description |
|---|---|---|
| Caffeine and Ritlecitinib | EXPERIMENTAL | In Period 1 Day 1, participants will be dosed with a single oral administration of caffeine 100 milligram (mg) tablet. In Period 2 Day 1 to Day 7, participants will be dosed with a single oral administration of ritlecitinib 200 milligram (mg) tablet. On Day 8, participants will be dosed with caffeine 100 milligram (mg) tablet within 5 minutes after administration of a 200 milligram (mg) dose of ritlecitinib on the morning of Day 8. Dosing with oral 200 milligram (mg) ritlecitinib QD will continue until Day 9. |
| Arm 1 - CYP Probe Cocktail | EXPERIMENTAL | Patients will receive a single oral dose of the CYP Probe Cocktail on Day -7, Day 1, and Day 14: * 25 mg losartan oral tablet * 30 mg dextromethorphan oral capsule * 50 mg caffeine oral liquid * 20 mg omeprazole oral capsule * 2 mg midazolam oral syrup encorafenib/binimetinib continuous daily dosing starting Day 1: * 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD) * 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID) All drugs will be taken within 10 minutes. |
| Arm 2 - Rosuvastatin and Bupropion | EXPERIMENTAL | Patients will receive a single oral dose of rosuvastatin and bupropion once on Day -7, Day 1 and Day 14: * 10 mg rosuvastatin oral tablet * 75 mg bupropion immediate release (IR) oral tablet encorafenib/binimetinib continuous daily dosing starting Day 1: * 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD) * 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID) All drugs will be taken within 10 minutes. |
| Arm 3 - Modafinil | EXPERIMENTAL | Patients will begin encorafenib/binimetinib continuous daily dosing starting Day 1: * 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD) * 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID) then receive continuous treatment of modafinil on Day 15 through Day 21: \- 400 mg modafinil tablet once daily (QD) |
| Name | Type | Description |
|---|---|---|
| Caffeine | DRUG | 100milligram (mg) tablet taken orally in period 1 and period 2 |
| Ritlecitinib | OTHER | 200 milligrams (mg) taken orally once a day(QD) for 8 days |
| losartan | DRUG | taken orally |
| dextromethorphan | DRUG | taken orally |
| omeprazole | DRUG | taken orally |
| midazolam | DRUG | taken orally |
| rosuvastatin | DRUG | taken orally |
| bupropion immediate release (IR) | DRUG | taken orally |
| encorafenib | DRUG | taken orally |
| binimetinib | DRUG | taken orally |
| modafinil | DRUG | taken orally |
Inclusion Criteria: -Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD. -BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). - * Male and female participants who are healthy as determined by medical evaluation including medical ...
Caffeine is an investigational small molecule being studied in clinical trials for healthy participants and advanced solid tumors. It is being evaluated as a probe drug in pharmacokinetic interaction studies, not as a therapeutic treatment for these conditions. The drug is in Phase 1 clinical development.
Caffeine does not have a specific molecular target or target class associated with its use in the clinical trials. It is being studied as a probe drug to assess potential drug-drug interactions with other investigational agents, rather than for its own therapeutic mechanism of action.
Caffeine is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate caffeine as a probe drug in pharmacokinetic studies.
Caffeine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities for any indication. The clinical trials involving caffeine are early-stage studies focused on pharmacokinetic interactions.
Caffeine has been studied in two completed Phase 1 clinical trials. NCT03864042 evaluated drug-drug interactions in patients with advanced solid tumors or metastatic melanoma, enrolling 56 participants. NCT04655040 assessed the effect of ritlecitinib on caffeine pharmacokinetics in healthy participants, enrolling 12 participants.
Caffeine is not known to have alternative names in the context of these clinical trials. It is being studied as a probe drug to evaluate potential interactions with other medications, but no other names for caffeine itself have been reported in the trial data.