New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
NCT Number: NCT05677867
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
New Haven, Connecticut, 06511, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Formulation A: administered as a 20 mg immediate release tablet and a 60 mg immediate release tablet
Formulation B: administered as a 80 mg immediate release tablet
Time frame: Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose on Day 1 of Period 1 and Period 2
AUCinf is the area under the concentration-time curve to infinity. AUCinf was calculated by AUClast + (Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Time frame: Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose on Day 1 of Period 1 and Period 2
AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast was calculated by Linear/Log trapezoidal method.
Time frame: Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose of Day 1 Period 1 and Period 2.
Cmax is the maximum observed concentration.
Time frame: From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)
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. A 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.
Time frame: Baseline (Day 1) up to Period 2 Day 5
Participants with laboratory abnormalities that met pre-specified criteria: Urate (millimole/Liter) > 1.2*ULN (upper limit of normal) and Monocytes/Leukocytes (%) > 1.2*ULN.
Time frame: Baseline (Day 1) up to Period 2 Day 5
Pre-specified criteria of vital signs included: Systolic blood pressure (BP): minimum (min) <90 mmHg, change from baseline (CfB) maximum (max) decrease or increase >=30mmHg; Diastolic BP min <50mmHg, CfB max decrease or increase >=20mmHg; supine pulse rate: min < 40 beats per minute (bpm), max > 120 bpm.
Time frame: Baseline (Day 1) up to Period 2 Day 5
The pre-specified criteria of ECG included: PR interval, aggregated: value >=300 msec, %change >= 25/50% msec; QRS duration, aggregated: value>=200 msec, %changes >= 25/50% msec; QTCF interval, aggregated: 450<=value<480 msec, 480<=value<500 msec, value>=500 msec, 30<=changes<60msec, and changes>=60msec.
Pfizer
Industry
A PHASE 1, OPEN-LABEL, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF 2 DIFFERENT FORMULATIONS OF PF-07081532 ADMINISTERED ORALLY TO ADULT PARTICIPANTS WHO ARE OVERWEIGHT OR OBESE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05929079
Apnea, Body Weight
Anniston, Alabama, United States
View Trial DetailsNCT00342732
Body Weight, Nutrition Disorders
Phoenix, Arizona, United States
View Trial DetailsNCT00445627
Body Weight, Diabetes Mellitus
Bethesda, Maryland, United States
View Trial DetailsNCT06904105
Body Weight, Nutrition Disorders
Beijing, Beijing Municipality, China
View Trial Details