Healthy Participants
Conditions
Keywords
abrocitinib, drug-drug interaction, omeprazole, caffeine, efavirenz
Brief summary
This is a Phase 1, open-label, multiple dose, single fixed-sequence, 2-period study to evaluate the effect of abrocitinib on the pharmacokinetics (PK) of caffeine, efavirenz and omeprazole in healthy adult participants. A total of approximately 13 healthy male and/or female participants will be enrolled in the study to obtain at least 12 evaluable participants who complete the study. Participants who withdraw from the study or are considered non-evaluable may be replaced at the discretion of the sponsor. Participants will be screened within 28 days of the first dose of study intervention. Participants will have a phone contact 3 days prior to Day 1 dosing (Day -3) in Period 1 as a reminder to abstain from caffeine-containing products. Participants will be admitted to the clinical research unit (CRU) at least 24 hours prior to Day 1 dosing (Day 1) in Period 1. Participants will remain in the CRU for a total of 15 days and 14 nights. Participants will have a telephone contact between 28-35 calendar days after the last administration of the investigational product.
Interventions
DRUGAbrocitinib
200 mg once daily (QD)
DRUGOmeprazole
single doses of 10 mg
DRUGCaffeine
single dose of 100 mg
DRUGEfavirenz
single doses of 50 mg
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participants must be ≥18 years of age at the time of signing the Informed consent document (ICD). 2. Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, laboratory tests, and cardiovascular tests. 3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 4. Body mass index (BMI) of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 lb). 5. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
1. Evidence or history of clinically significant hematological, renal, endocrine, neurological diseases, or other systems diseases, allergic diseases including drug allergies but excluding untreated asymptomatic seasonal allergies at the time of dosing 2. Subjects with moderate to severe gastroesophageal reflux disease (GERD) symptoms, or any condition affecting drug absorption e.g. gastrectomy, cholecystectomy 3. History of human immunodeficiency virus (HIV) infection, positive test for HIV, hepatitis B, hepatitis C, positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb). Subjects previously vaccinated for hepatitis B may be allowed. However, subjects vaccinated with vaccines having live or attenuated components within 6 weeks of the first dose of study drug, or expecting to be vaccinated during the course of the trial are excluded. 4. Any psychiatric condition including recent or active suicidal ideation or behavior, other psychiatric conditions that may increase the risk of study participation, or, in the investigator's judgement, make the subject inappropriate for the study. 5. Evidence or history of clinically significant dermatological conditions, e.g. atopic dermatitis (AD) or psoriasis, or visible rash present during physical examination, history of disseminated herpes zoster or disseminated herpes simplex, or localized dermatomal herpes zoster. 6. History of chronic infections, recurrent infections or latent infections, e.g. tuberculosis (TB); Positive QuantiFERONE® TB GOLD test, any acute infection within 2-weeks of baseline (Day-1). 7. Malignancies or history of malignancies except for adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. 8. History of hypersensitivity, intolerance, or allergic reaction associated with prior exposure to caffeine, omeprazole, efavirenz and abrocitinib or any of their excipients. 9. Subjects who may be at increased risk if dosed with efavirenz, including severe hepatic impairment (Child Pugh Class C), or a history of seizures. 10. Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug; herbal supplements and hormonal contraceptives and hormone replacement therapy (HRT) must be discontinued at least 28 days prior to the first dose of the investigational product; Depo-Provera® must be discontinued at least 6 months prior to dosing with investigational product. 11. Systemic therapy with any of the medicines that are moderate or strong cytochrome P450 (CYP)1A2, CYP2B6, or CYP2C19 inhibitors within 28 days or 5 half-lives (whichever is longer), or moderate or strong CYP1A2, CYP2B6 or CYP2C19 inducers within 28 days or 5-half-lives (whichever is longer) prior to the first dose. 12. Previous administration with any investigational drug within 30 days (or as determined by local requirements), or 5-half-lives preceding the first dose of study drug intervention used in this study (whichever is longer). 13. Smokers and/or subjects who used nicotine-based products within three months prior to the first dose of the investigational product. 14. Screening supine blood pressure (BP)≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at last 5 minutes of supine rest. If BP≥140 mmHg (systolic) or ≥90 mmHg (diastolic), the BP should be repeated 2 more times and the average of the 3BP values should be used to determine the subject's eligibility. 15. Abnormal baseline standard 12-lead electrocardiogram (ECG), QT interval \>450 msec, QTcF\>450 msec, . If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the subjects eligibility. Computer-interpreted ECGs should be 0ver-read by a physician experienced in reading ECGs before excluding a subject. 16. Subjects with abnormal blood chemistry; abnormal hematology including complete WBC count and differentials; estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 17. History of alcohol abuse, binge drinking, or any illicit drug use or dependence within 6 months of screening. Positive urine drug test. 18. Pregnant females, breastfeeding females, female subjects of childbearing potential who are unwilling or unable to use one highly effective method of contraception as outlined in the protocol for the duration of the study and for at least, 28 days after the last dose of study intervention. Unwilling to comply with lifestyle considerations in the protocol. 19. Subjects who routinely consume more than five 8-ounce cups of coffee (or caffeine equivalent), or greater than 6 servings (1 serving is approximately equivalent to 125 mg of caffeine) of tea, cola or other caffeinated beverage per day. 20. Consumption of chocolate and chocolate-containing products (e.g. hot chocolate, ice cream, cookies, etc) within 48 hours prior to the first dose of study drug and during the study. 21. Consumption of charcoal-broiled beef within 7 days prior to the first dose of study drug as it is known to induce CYP1A2 enzyme. 22. Consumption of cruciferous vegetables (e.g. cauliflower, broccoli, Brussel sprouts and cabbage) within 7 days prior to the first dose of study drug as cruciferous vegetables are known to increase CYP1A2 activity 23. Blood donation (excluding plasma donation) of approximately 1 pint (500 ml) or more within 60 days prior to dosing. 24. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator and their respective family members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Omeprazole | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 1 Period 1 and Day 8 Period 2 | AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. |
| AUCinf Corrected for Residual Concentrations (AUCinfCR) of Caffeine | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 1 Period 1 and Day 8 Period 2 | AUCinfCR was defined as AUCinf corrected for residual concentrations. AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Two participants in Period 1 and 1 participant in Period 2 had pre-dose caffeine concentrations that were greater than 5% of the corresponding maximum plasma concentration (Cmax). Therefore, AUCinf was corrected for the residual concentrations for these participants. |
| Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration Corrected for Residual Concentrations (AUClastCR) of Efavirenz | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 1 Period 1 and Day 8 Period 2 | AUClastCR was defined as AUClast corrected for residual concentrations. AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. Eight participants in Period 2 had pre-dose efavirenz concentrations that were greater than 5% of the corresponding Cmax. Therefore, AUClast was corrected for the residual concentrations for these participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 48 days after the first dose in period 1. This includes 3 days of period 1, 10 days of period 2 and 28-25 days of the follow-up period. | Adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or worsened relative to pretreatment state. An SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect. |
| Number of Participants With Clinically Significant Change in Vital Signs | At screening, on Day 1 Period 1 and Day 11 Period 2 | Vital sign measurements included supine blood pressure, pulse rate, respiratory rate, and temperature. Any safety assessments (vital sign measurements) including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the investigator were considered meeting the AE definition and are listed below. Only those categories in which at least 1 participant had data were reported. |
| Number of Participants With Treatment-Related TEAEs and SAEs | Up to 48 days after the first dose in period 1. This includes 3 days of period 1, 10 days of period 2 and 28-25 days of the follow-up period. | Adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or worsened relative to pretreatment state. An SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect. Causality of the TEAEs and SAEs was judged by the investigator. |
| Number of Participants With Laboratory Abnormalities Regardless of Baseline | At screening, on Day -1 Period 1 and Day 11 Period 2 | Hematology parameters included hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, cystatin C, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Only those categories in which at least 1 participant had data were reported. Number of Participants With Laboratory Abnormalities Regardless of Baseline in data table indicates the number of participants who had the laboratory abnormality at least 1 of the timepoints when the laboratory tests were done. |
Countries
United States
Participant flow
Pre-assignment details
A total of 26 participants were assigned and dosed in this study. In addition to the initial 13 participants planned, this study enrolled 13 replacement participants due to pharmacokinetic (PK) sample lost and remaining samples being not evaluable. Thus only 13 participants were included in the PK analysis.
Participants by arm
| Arm | Count |
|---|---|
| Periods 1 and 2 Healthy participants received single oral doses of caffeine 100 mg, efavirenz 50 mg, and omeprazole 10 mg together following an overnight fast on Day 1 Period 1. They received abrocitinib 200 mg orally QD on Days 1 - 10 Period 2, a single oral dose of omeprazole 10 mg on Day 2 Period 2, and single oral doses of caffeine 100 mg, efavirenz 50 mg, and omeprazole 10 mg together on Day 8 Period 2. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Periods 1 and 2 |
|---|---|
| Age, Customized <18 | 0 Participants |
| Age, Customized 18-44 | 16 Participants |
| Age, Customized 45-64 | 10 Participants |
| Age, Customized >=65 | 0 Participants |
| Body Mass Index | 26.72 kg/m^2 |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized White | 23 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 2 / 26 | 0 / 26 | 3 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 0 / 26 |
Outcome results
Primary
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Omeprazole
AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 1 Period 1 and Day 8 Period 2
Population: This study enrolled 13 replacement participants as some of the pharmacokinetic (PK) samples from Day 8 Period 2 collected from the initial 13 participants were lost in transit and remaining samples were not evaluable. The PK data collected from the 13 replacement participants were included in the following descriptive and statistical summaries.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Omeprazole | 238.5 ng*hr/mL | Geometric Coefficient of Variation 101 |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Omeprazole | 688.8 ng*hr/mL | Geometric Coefficient of Variation 90 |
Comparison: Omeprazole 10 mg was Reference and abrocitinib 200 mg + omeprazole 10 mg was Test. Natural log-transformed AUCinf was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.90% CI: [240.56, 346.73]
Primary
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration Corrected for Residual Concentrations (AUClastCR) of Efavirenz
AUClastCR was defined as AUClast corrected for residual concentrations. AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. Eight participants in Period 2 had pre-dose efavirenz concentrations that were greater than 5% of the corresponding Cmax. Therefore, AUClast was corrected for the residual concentrations for these participants.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 1 Period 1 and Day 8 Period 2
Population: This study enrolled 13 replacement participants as some of the PK samples from Day 8 Period 2 collected from the initial 13 participants were lost in transit and remaining samples were not evaluable. The PK data collected from the 13 replacement participants were included in the following descriptive and statistical summaries.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration Corrected for Residual Concentrations (AUClastCR) of Efavirenz | 5588 ng*hr/mL | Geometric Coefficient of Variation 20 |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration Corrected for Residual Concentrations (AUClastCR) of Efavirenz | 6153 ng*hr/mL | Geometric Coefficient of Variation 24 |
Comparison: Efavirenz 50 mg was Reference and abrocitinib 200 mg + efavirenz 50 mg was Test. Natural log-transformed AUClastCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.90% CI: [103.45, 117.17]
Primary
AUCinf Corrected for Residual Concentrations (AUCinfCR) of Caffeine
AUCinfCR was defined as AUCinf corrected for residual concentrations. AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Two participants in Period 1 and 1 participant in Period 2 had pre-dose caffeine concentrations that were greater than 5% of the corresponding maximum plasma concentration (Cmax). Therefore, AUCinf was corrected for the residual concentrations for these participants.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 1 Period 1 and Day 8 Period 2
Population: This study enrolled 13 replacement participants as some of the PK samples from Day 8 Period 2 collected from the initial 13 participants were lost in transit and remaining samples were not evaluable. The PK data collected from the 13 replacement participants were included in the following descriptive and statistical summaries.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | AUCinf Corrected for Residual Concentrations (AUCinfCR) of Caffeine | 19730 ng*hr/mL | Geometric Coefficient of Variation 46 |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | AUCinf Corrected for Residual Concentrations (AUCinfCR) of Caffeine | 26880 ng*hr/mL | Geometric Coefficient of Variation 28 |
Comparison: Caffeine 100 mg was Reference and abrocitinib 200 mg + caffeine 100 mg was Test. Natural log-transformed AUCinfCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.90% CI: [121.98, 159.74]
Secondary
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or worsened relative to pretreatment state. An SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect.
Time frame: Up to 48 days after the first dose in period 1. This includes 3 days of period 1, 10 days of period 2 and 28-25 days of the follow-up period.
Population: All 26 participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 3 Participants |
| Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 1 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 5 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Secondary
Number of Participants With Clinically Significant Change in Vital Signs
Vital sign measurements included supine blood pressure, pulse rate, respiratory rate, and temperature. Any safety assessments (vital sign measurements) including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the investigator were considered meeting the AE definition and are listed below. Only those categories in which at least 1 participant had data were reported.
Time frame: At screening, on Day 1 Period 1 and Day 11 Period 2
Population: All 26 participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Clinically Significant Change in Vital Signs | 0 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Clinically Significant Change in Vital Signs | 0 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Clinically Significant Change in Vital Signs | 2 Participants |
Secondary
Number of Participants With Laboratory Abnormalities Regardless of Baseline
Hematology parameters included hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, cystatin C, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Only those categories in which at least 1 participant had data were reported. Number of Participants With Laboratory Abnormalities Regardless of Baseline in data table indicates the number of participants who had the laboratory abnormality at least 1 of the timepoints when the laboratory tests were done.
Time frame: At screening, on Day -1 Period 1 and Day 11 Period 2
Population: All 26 participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Laboratory Abnormalities Regardless of Baseline | Neutrophils >1.2x upper limit of normal (ULN) | 0 Participants |
| Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Laboratory Abnormalities Regardless of Baseline | Urine hemoglobin >=1 | 0 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Laboratory Abnormalities Regardless of Baseline | Neutrophils >1.2x upper limit of normal (ULN) | 0 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Laboratory Abnormalities Regardless of Baseline | Urine hemoglobin >=1 | 0 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Laboratory Abnormalities Regardless of Baseline | Neutrophils >1.2x upper limit of normal (ULN) | 1 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Laboratory Abnormalities Regardless of Baseline | Urine hemoglobin >=1 | 7 Participants |
Secondary
Number of Participants With Treatment-Related TEAEs and SAEs
Adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or worsened relative to pretreatment state. An SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect. Causality of the TEAEs and SAEs was judged by the investigator.
Time frame: Up to 48 days after the first dose in period 1. This includes 3 days of period 1, 10 days of period 2 and 28-25 days of the follow-up period.
Population: All 26 participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Treatment-Related TEAEs and SAEs | TEAEs | 2 Participants |
| Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Treatment-Related TEAEs and SAEs | SAEs | 0 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Treatment-Related TEAEs and SAEs | TEAEs | 0 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Treatment-Related TEAEs and SAEs | SAEs | 0 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Treatment-Related TEAEs and SAEs | TEAEs | 1 Participants |
| Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg | Number of Participants With Treatment-Related TEAEs and SAEs | SAEs | 0 Participants |