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Clinical Trial Details

Trial ID: L6337
Source ID: NCT04305587
Associated Drug: Pf-07081532
Title: Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04305587/results
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: PF-07081532|OTHER: Placebo|DRUG: Clopidogrel
Outcome Measures: Primary: Number of Participants With Treatment Emergent Treatment-Related Adverse Events, An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. Treatment-emergent are events between first dose of study intervention and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state., From the first dose up to 28-35 days after last administration of study intervention (that is a maximum of 63 days from first dose for Part A and a maximum of 77 days from first dose for Part B and Part C)|Number of Participants With Laboratory Abnormalities, Participants with laboratory abnormalities with ≥2 occurrences (without regard to baseline abnormality) that met pre-specified criteria were High-density lipoprotein (HDL) Cholesterol \<0.8✕ lower limit of normal (LLN); Bicarbonate \<0.9✕LLN; Calcitonin\>1.0✕upper limit of normal (ULN); Triglycerides \>1.3✕ULN; Aspartate Aminotransferase \>3.0✕ULN; Low-density lipoprotein (LDL) Cholesterol \>1.2✕ULN; Urine Glucose ≥1; Urine Ketones ≥1; Urine Leukocyte Esterase ≥1; Urine Leukocytes ≥20; Urine Hyaline Casts \>1; Urine Hemoglobin ≥1; and Urine Nitrite ≥1., From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)|Number of Participants With Vital Signs Abnormalities, Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure \< 90 millimeters of mercury (mmHg), supine systolic blood pressure increase/decrease from baseline ≥ 30mmHg; supine diastolic blood pressure \<50 mmHg, supine diastolic blood pressure increase/decrease from baseline ≥ 20mmHg; pulse rate \<40 beats per minute (bpm) or \>120 bpm., From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)|Number of Participants With Abnormal Electrocardiogram (ECG), The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥ 300 milliseconds (msec), percentage change ≥ 25/50%; QRS duration: value ≥140 msec, percentage change ≥ 50%; QTcF interval: 450 \< value ≤ 480 msec, 480 \< value ≤ 500 msec, value \>500 msec, and 30\<change ≤ 60 msec, change \>60 msec., From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C) | Secondary: Area Under the Curve From Time 0 to 24 Hours (AUC24) Post Dose for PF-07081532, AUC24 is defined as area under the concentration-time profile from time 0 to 24 hours using Linear/Log trapezoidal method., 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C|Maximum Observed Plasma Concentration (Cmax) for PF-07081532, Cmax is defined as maximum plasma concentration observed directly from data., 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-07081532, Tmax is defined as time for Cmax observed directly from data as time of first occurrence., 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C|Time Measured for the Plasma Concentration to Decrease by One-Half (t1/2) for PF-07081532, t1/2 is defined as the time measured for the plasma concentration to decrease by one half., 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Day 28 for Part A, on Day 42 for Part B and Part C|Cumulative Amount of Drug Recovered Unchanged in Urine Over 24 Hours (Ae24) for PF-07081532, Ae24 is defined as cumulative amount of drug recovered unchanged in urine over 24 hours using the method of urine concentration \* volume of urine., Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)|Percentage of Ae24 (Ae24%) for PF-07081532, Ae24% is defined as percent of dose recovered unchanged in urine over the 24 hours using the method of 100 \* Ae24/Dose, Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)|Renal Clearance (CLr) for PF-07081532, Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine over the dosing interval tau (Aetau) divided by area under the concentration time-curve from time 0 to time tau (AUCtau), Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 66
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2020-03-16
Completion Date: 2021-07-14
Results First Posted: 2024-02-05
Last Update Posted: 2024-02-05
Locations: Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States|Qps-Mra, Llc, South Miami, Florida, 33143, United States
URL: https://clinicaltrials.gov/show/NCT04305587