Phase 1
Completed N=20
A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese
Source: ClinicalTrials.gov NCT05677867 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Pharmacokinetics Parameter - Area Under the Concentration-Time Curve to Infinity (AUCinf) of PF-07081532 — 179400; 178300 nanogram*hour/milliliter (ng*hr/mL)
Summary
The purpose of this study is to compare the amount of PF-07081532 in blood after taking two different forms of PF-07081532. This study is seeking participants who are at least 18 years of age and are overweight and/or obese. All study participants will receive a total of 2 single doses of this study medication in either form. Form A consists of a PF-07081532 20 mg immediate release tablet and a PF-07081532 60 mg immediate release tablet. Form B consists of a PF-07081532 80 mg immediate release tablet. Each single dose will be separated by a minimum of 6 days. The amount of PF-07081532 in the blood for 4 days after taking each single dose will be compared between the two different formulations of PF-07081532.
The total time that participants will take part in this study is about 70 days. The first visit is a screening visit to ensure that participants are appropriately qualified for the study. This will occur up to 28 days before the first single dose. Participants will be admitted into the clinic one day prior to the first single dose and will remain in the clinic for a total of 11 days. The study team will phone the participants 28 to 35 days after the last dose of study medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics Parameter - Area Under the Concentration-Time Curve to Infinity (AUCinf) of PF-07081532 |
179400; 178300 | — |
| PRIMARY Pharmacokinetics Parameter - Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532 |
171900; 170400 | — |
| PRIMARY Pharmacokinetics Parameter - Maximum Observed Concentration (Cmax) of PF-07081532 |
8072; 7741 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All-Causality and Treatment-Related) |
9; 8; 9; 8; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
0; 1; 0; 1 | — |
| SECONDARY Number of Participants Meeting Pre-Specified Criteria of Vital Signs |
0; 0 | — |
| SECONDARY Number of Participants Meeting Pre-Specified Criteria of Electrocardiogram (ECGs) |
0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female participants must be at least 18 years of age, inclusive, at the time of signing the ICD
- Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECGs
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
- A total body weight >50 kg (110 lb) and BMI of 25.0 to 450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT interval is >450 ms, this interval should be rate-corrected using the Fridericia method only and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
- Aspartate aminotransferase or alanine aminotransferase level ≥1.25 × upper limit of normal (ULN);
- Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN;
- HbA1c ≥6.5%;
- Fasting blood glucose ≥126 mg/dL (7 mmol/L);
- Calcitonin > ULN;
- eGFR <60 mL/min/1.73 m2 as calculated by the CKD-EPI equation.
Data sourced from ClinicalTrials.gov (NCT05677867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.