A Study to Learn About Study Medicine Called PF-07261271 in Healthy People
- Registration Number
- NCT05536440
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine PF-07261271 for the potential treatment of Inflammatory Bowel Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- Healthy individuals as determined by medical evaluation
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Clinically significant medical conditions
- History of HIV infection, hepatitis B, or hepatitis C
- BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic)
- Clinically relevant ECG abnormalities
- Previous study drug administration within 30 days or 5 half-lives of first planned dose
- History of drug/alcohol abuse or >20 cigarettes/day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 active PF-07261271 Dose A Cohort 1 placebo Placebo Dose A Cohort 2 placebo Placebo Dose B Cohort 3 placebo Placebo Dose C Cohort 4 active PF-07261271 Dose D Cohort 4 placebo Placebo Dose D Cohort 5 active PF-07261271 Dose E Cohort 5 placebo Placebo Dose E Cohort 6 active PF-07261271 Dose F Cohort 6 placebo Placebo Dose F Cohort 7 active PF-07261271 Dose G Cohort 7 placebo Placebo Dose G Cohort 8 active PF-07261271 Dose H Cohort 8 placebo Placebo Dose H Cohort 2 active PF-07261271 Dose B Cohort 3 active PF-07261271 Dose C
- Primary Outcome Measures
Name Time Method Number of Participants With Serious Adverse Events (SAEs): MD Cohort From start of study intervention (Day 1) up to end of study, approximately of 15.5 months An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: 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, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medically significant event.
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: SAD Cohort From start of study intervention (Day 1) up to end of study, approximately up to 15 months Criteria for abnormal values of vital signs: systolic blood pressure (millimeters of mercury \[mmHg\]) value less than (\<) 90 mmHg, change greater than or equal to (\>=) 30 mmHg increase, change \>= 30 mmHg decrease; diastolic blood pressure (mmHg), value \<50 mmHg, change \>=20 mmHg increase, change \>=20 mmHg decrease; pulse rate (beats per minute \[bpm\]) value \<40bpm, value greater than (\>) 120bpm. Clinical significance was determined based on investigator's discretion.
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: MD Cohort From start of study intervention (Day 1) up to end of study, approximately of 15.5 months Criteria for abnormal values of vital signs: systolic blood pressure (mmHg) value \< 90 mmHg, change \>= 30 mmHg increase, change \>= 30 mmHg decrease; diastolic blood pressure (mmHg), value \<50 mmHg, change \>=20 mmHg increase, change \>=20 mmHg decrease; pulse rate (bpm) value \< 40bpm, value \> 120bpm. Clinical significance was determined based on investigator's discretion.
Number of Participants With Treatment Emergent Adverse Events (TEAEs): SAD Cohort From start of study intervention (Day 1) up to end of study, approximately up to 15 months An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the last follow-up date, were considered as TEAEs. AEs included all SAEs and Non-SAEs.
Number of Participants With Treatment Emergent Adverse Events (TEAEs): MD Cohort From start of study intervention (Day 1) up to end of study, approximately of 15.5 months An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the last follow-up date, were considered as TEAEs. AEs included all SAEs and Non-SAEs.
Number of Participants With Serious Adverse Events (SAEs): SAD Cohort From start of study intervention (Day 1) up to end of study, approximately up to 15 months An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: 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, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medically significant event.
Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: SAD Cohort From start of study intervention (Day 1) up to end of study, approximately up to 15 months Criteria:Hematology(Activated partial thromboplastin time\>1.1\*upper limit of normal(ULN); Basophils \&eosinophils\>1.2\*ULN; erythrocytes,hematocrit,hemoglobin,lymphocytes,neutrophils \<0.8\*lower limit of normal(LLN); leukocytes \<0.6\*LLN, \>1.5\*ULN; monocytes \>1.2\*ULN; platelets \<0.5\*LLN; prothrombin international randomized ratio \&prothrombin Time \>1.1\*ULN), clinical chemistry (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase \>3.0\*ULN; albumin, protein \<0.8\*LLN, \>1.2\*ULN; bicarbonate, calcium, chloride, potassium \<0.9\*LLN,\>1.1\*ULN; bilirubin \>1.5\*ULN; creatinine \>1.3\*ULN; glucose, Glucose-FASTING \<0.6\*LLN,\>1.5\*ULN; Sodium \<0.95\*LLN,\>1.05\*ULN; Urate: \>1.2\*ULN;Urea Nitrogen: \>1.3\*ULN),urinalysis(Bacteria \> 20;epithelial cells \>=6;granular, hyaline, RBC\&WBC casts \>1;ketones,leukocyte esterase, nitrite, urine glucose, urine hemoglobin, urine protein\>=1,urine erythrocytes,leukocytes \>=20;pH(scalar)\<4.5,\>8.Clinical significance determined on investigator's discretion.
Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: MD Cohort From start of study intervention (Day 1) up to end of study, approximately of 15.5 months Criteria:Hematology(Activated partial thromboplastin time\>1.1\*upper limit of normal(ULN); Basophils \&eosinophils\>1.2\*ULN; erythrocytes,hematocrit,hemoglobin,lymphocytes,neutrophils \<0.8\*lower limit of normal(LLN); leukocytes \<0.6\*LLN, \>1.5\*ULN; monocytes \>1.2\*ULN; platelets \<0.5\*LLN; prothrombin international randomized ratio \&prothrombin Time \>1.1\*ULN), clinical chemistry (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase \>3.0\*ULN; albumin, protein \<0.8\*LLN, \>1.2\*ULN; bicarbonate, calcium, chloride, potassium \<0.9\*LLN,\>1.1\*ULN; bilirubin \>1.5\*ULN; creatinine \>1.3\*ULN; glucose, Glucose-FASTING \<0.6\*LLN,\>1.5\*ULN; Sodium \<0.95\*LLN,\>1.05\*ULN; Urate: \>1.2\*ULN;Urea Nitrogen: \>1.3\*ULN),urinalysis(Bacteria \> 20;epithelial cells \>=6;granular, hyaline, RBC\&WBC casts \>1;ketones,leukocyte esterase, nitrite, urine glucose, urine hemoglobin, urine protein\>=1,urine erythrocytes,leukocytes \>=20;pH(scalar)\<4.5,\>8.Clinical significance determined on investigator's discretion.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Abnormalities: SAD Cohort From start of study intervention (Day 1) up to end of study, approximately up to 15 months Criteria for abnormal values of ECG parameters: pulse rate (PR) interval greater than or equal to (\>=)300 milliseconds (msec); PR interval change \>=25 percent (%) or \>=50 %, QRS interval \>=140 msec and QRS interval change: \>=50%. QT interval using Fridericia's correction (QTcF) range from 450 msec to less than (\<)480 msec, less than (\<) 480 msec to maximum less than or equal to (\<=)500 msec, \>500 msec, \<=30 to \<60 msec and \>=60 msec. Only rows which included at least 1 participant with abnormality are reported in this outcome measure. Clinical significance was determined based on investigator's discretion.
Number of Participants With Clinically Significant Changes in ECG Abnormalities: MD Cohort From start of study intervention (Day 1) up to end of study, approximately of 15.5 months Criteria for abnormal values of ECG parameters: pulse rate (PR) interval greater than or equal to (\>=)300 milliseconds (msec); PR interval change \>=25 percent (%) or \>=50 %, QRS interval \>=140 msec and QRS interval change: \>=50%. QT interval using Fridericia's correction (QTcF) range from 450 msec to less than (\<)480 msec, less than (\<) 480 msec to maximum less than or equal to (\<=)500 msec, \>500 msec, \<=30 to \<60 msec and \>=60 msec. Only rows which included at least 1 participant with abnormality are reported in this outcome measure. Clinical significance was determined based on investigator's discretion.
- Secondary Outcome Measures
Name Time Method Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07261271: SAD Cohort Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose AUCinf was determined as AUClast + (Clast\*/kel), where Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Time to Maximum Plasma Concentration (Tmax) of PF-07261271: SAD Cohort Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose Tmax was defined as time for Cmax.
Terminal Elimination Half-life (t1/2) of PF-07261271: SAD Cohort Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose t1/2 was determined using Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear -concentration time- curve.
Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Time Point (AUClast) of PF-07261271: SAD Cohort Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose AUClast was determined using Linear Log trapezoidal method.
Maximum Plasma Concentration (Cmax) of PF-07261271: SAD Cohort Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose Cmax was defined as maximum serum concentration.
Area Under the Concentration Time Profile From Time Zero to Time Tau (τ), the Dosing Interval (AUCtau) of PF-07261271: MD Cohort Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 AUCtau was defined as area under the concentration time profile from time zero to time tau (τ), the dosing interval, where tau=672 hours for every 4-week dosing. AUCtau was determined by Linear Log trapezoidal method.
Cmax of PF-07261271: MD Cohort Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 Cmax was defined as maximum serum concentration.
Tmax of PF-07261271: MD Cohort Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 Tmax was defined as time for Cmax.
Terminal Elimination Half-life (t1/2) of PF-07261271: MD Cohort Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 t1/2 was determined using Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear -concentration time- curve.
Number of Participants With Anti-drug Antibodies (ADA) Against PF-07261271: SAD Cohort Baseline up to 15 months ADA positive was defined as ADA titer \>= 100; ADA negative defined as ADA titer \< 100. Baseline was defined as the last pre-dose measurement
Number of Participants With ADA Against PF-07261271: MD Cohort Baseline up to 15.5 months ADA positive defined as ADA titer \>= 100; ADA negative defined as ADA titer \< 100. Baseline was defined as the last pre-dose measurement.
Number of Participants With Neutralizing Antibodies (NAb) Against PF-07261271: SAD Cohort Baseline up to 15 months NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform.
Number of Participants With NAb Against PF-07261271: MD Cohort Baseline up to 15.5 months NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform.
Trial Locations
- Locations (3)
Clinilabs
🇺🇸Eatontown, New Jersey, United States
ICON
🇺🇸Salt Lake City, Utah, United States
Orange County Research Center
🇺🇸Tustin, California, United States