PF-06842874
DrugSingle dose administration of PF-06842874
NCT Number: NCT04124653
This study will be the first time PF-06842874 is administered to humans. The purpose of Part A of the study is to investigate the safety, tolerability, and pharmacokinetics of PF-06842874 following administration of single oral doses as an immediate-release or modified-release formulation to healthy adult participants. Part B of this study will evaluate the relative bioavailability of a modified-release formulation of PF-06842874 for its potential use in future clinical studies. The effect of food on PF-06842874 pharmacokinetics may also be evaluated in this study.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
New Haven Clinical Research Unit, New Haven, Connecticut, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose administration of PF-06842874
Single dose administration of placebo
Relative bioavailability assessment of modified-release formulation
Time frame: Baseline up to 35 days after last dose of study medication
Treatment-related AEs are any untoward medical occurrences attributed to study drug in a participant who received study drug.
Time frame: Baseline up to 10 days after last dose of study medication
The following parameters will be analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).
Time frame: 0, 1, 2, 3, 5, 8, 12, 24, and 48 hours post-dose
The following parameters will be analyzed for examination of vital signs: systolic blood pressure, diastolic blood pressure, and pulse rate.
Time frame: 0, 1, 2, 3, 5, 8, 12, 24, and 48 hours post-dose
Measurements of heart rate, PR interval, QT interval, QTc intervals, and QRS complex
Time frame: 0 to 8 hours post-dose
Cardiac rhythms measured by continuous cardiac telemetry
Time frame: Baseline up to 10 days after last dose of study medication
A complete physical examination includes, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A limited physical examination includes, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms.
Time frame: 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose
Maximum observed plasma concentration for immediate-release and modified-release formulations of PF-06842874
Time frame: 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for immediate-release and modified-release formulations of PF-06842874
Time frame: 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose
Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0-inf) for immediate-release and modified-release formulations of PF-06842874. It is obtained from AUC(0-t) plus AUC (t-inf).
Time frame: 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose
Time to reach maximum observed plasma concentration for immediate-release and modified-release formulations of PF-06842874
Time frame: 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose
Plasma half-life is the time measured for the plasma concentration to decrease by one half for immediate-release and modified-release formulations of PF-06842874.
Pfizer
Industry
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-06842874 ADMINISTERED AS AN IMMEDIATE-RELEASE OR MODIFIED-RELEASE FORMULATION TO HEALTHY ADULT PARTICIPANTS AND AN OPEN-LABEL ASSESSMENT OF THE RELATIVE BIOAVAILABILITY OF A MODIFIED-RELEASE FORMULATION OF PF-06842874
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.
NCT05870072
Balance, Postural, Behavior
Kütahya, Centre, Turkey (Türkiye)
View Trial DetailsNCT07241065
Healthy Participants
Berlin, Germany
View Trial DetailsNCT07214766
Healthy Participants
Anaheim, California, United States
View Trial DetailsNCT07444424
Body Weight, Diabetes Mellitus
Fukuoka, Japan
View Trial Details