Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
NCT Number: NCT05673889
The purpose of this study is to understand if ARV-471 affects how a medicine called, dabigatran etexilate, gets absorbed or processed into the body in healthy adults.
All participants in this study will receive one dose of dabigatran etexilate alone by mouth in Period 1. In Period 2, everyone will receive one dose of dabigatran etexilate by mouth approximately 90 minutes after receiving one dose of ARV-471 by mouth. The levels of dabigatran in Period 1 will be compared to the levels of dabigatran in Period 2. This will help us to determine if and how ARV-471 affects dabigatran gets absorbed into the body differently in healthy adults.
All participants will stay at the study clinic for approximately 8 days and 7 nights.
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Notify Me18 year–70 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.
Inclusion criteria
Exclusion criteria
Experimental
Other names: PF-07850327
Probe substrate
Other names: PRADAXA®
Time frame: Period 1 and 2: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose on Day 1
Cmax was defined as maximum observed plasma concentration. Cmax for total dabigatran was observed directly from data.
Time frame: Period 1 and 2: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose on Day 1
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time frame: From the first dose (Day 1) up to 35 days after the last dose (Day 5) of study intervention (up to 40 days)
An AE is any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship with the study intervention. SAE is defined as one of the following: is fatal or life threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE is defined as an AE with onset date occurring during the on-treatment period. AEs include all SAEs and non-SAEs.
Time frame: Baseline (Period 1 Day -1) up to Period 2 Day 3 (8 days)
Following parameters were 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, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid, cystatinC); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (dipstick [decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, bilirubin], microscopy. Abnormality was determined at the investigator's discretion.
Time frame: Baseline (Period 1 Day 1) up to Period 2 Day 3 (7 days)
Vital signs (blood pressure and pulse rate) were obtained with participant following at least a 5-minute rest in a supine position. Clinical significance of vital signs was determined at the investigator's discretion.
Time frame: Baseline (Period 1 Day 1) up to Period 2 Day 3 (7 days)
ECG abnormalities criteria include a) a postdose QTc corrected using Fridericia's formula (QTcF) increased by >60 millisecond (ms) from the baseline and the absolute QTcF value >450 ms; or b) an absolute QTcF value >500 ms for any scheduled ECG.
Pfizer
Industry
AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY TO EVALUATE THE EFFECT OF A SINGLE ORAL DOSE OF ARV-471 (PF-07850327) ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY 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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