Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
NCT Number: NCT05907395
The purposes of the study are:
To learn about the safety and tolerability of study medicine (PF-07293893). Tolerability is the extent to which side effects can be tolerated. Side effects are unwanted reactions to the study medicine.
To measure the amount of PF-07293893 in blood after the medicine is taken by mouth.
The study is seeking participants who:
* Are females of non-childbearing potential and males 18 to 65 years of age * Are in generally healthy condition * Have not had viral infections (HIV, HBV or HCV). HIV, human immunodeficiency virus. HBV, human hepatitis B virus. HCV, human hepatitis C virus.
Participants will receive either PF-07293893 or placebo (dummy pill) by chance. Participants will undergo up to 4 treatments periods in this study. Everyone will receive up to 4 doses of study medicine and up to 2 doses of placebo. In each period, participants will stay in study clinic for 5 days. There will be at least 2 days between each treatment period.
Participants will be involved in this study for about 14 weeks. During their stay, participants will undergo several examinations. Participants will also have their blood collected by the study doctors for several times.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
This study is seeking participants who are:
This study is not seeking participants who have:
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≥1.05 × upper limit of normal (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.
PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined.
Matching placebo will be prepared as an oral suspension given in each cohort.
Time frame: Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
An Adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events with onset dates on or after the start of the study drug.
Time frame: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
Following parameters were analyzed for laboratory abnormalities: hematology (lymphocytes <0.8*lower limit of normal [LLN], lymphocytes/leukocytes <0.8*LLN, neutrophils <0.8*LLN, neutrophils/leukocytes <0.8*LLN, eosinophils/leukocytes >1.2*upper limit of normal [ULN], monocytes >1.2*ULN, monocytes/leukocytes >1.2*ULN); clinical chemistry (aspartate aminotransferase >3.0*ULN, potassium >1.1*ULN, creatine kinase >2.0*ULN); urinalysis (urine specific gravity <1.003 ,>1.030, ketones >=1, urine hemoglobin >=1, urobilinogen >=1, urine bilirubin >=1, leukocyte esterase >=1). In this outcome measure, participants with any laboratory abnormalities are reported.
Time frame: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
Vital signs assessments included blood pressure, pulse rate, respiratory rate and body temperature. Clinical significance of vital signs was determined based by investigator's discretion.
Time frame: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
ECG parameters included heart rate, PR interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. Clinically significant ECG findings were determined by the investigator's discretion.
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
AUClast was calculated using linear/log trapezoidal method.
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
AUCinf was calculated as AUClast + (Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period
t1/2 was calculated as log^e (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Pfizer
Industry
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07293893 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS
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.
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