Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
NCT Number: NCT06105983
The purpose of this study is to see how rabeprazole affects the level of the study medicine sisunatovir in the blood of healthy adult participants. Rabeprazole is a medicine that reduces the amount of acid the stomach makes.
The information from this study may inform how sisunatovir will be used in the future with medicines that reduce stomach acid.
This study is seeking healthy participants who:
* are aged 18 years of age or older. * are confirmed to be healthy by some medical tests. This study can include both men and women. Women who can produce a baby must agree to use a highly effective method of birth control. * have body mass index (BMI) of 16 to 32 kilograms per meter squared. * a total body weight of more than 45 kilograms. Participants will receive sisunatovir tablets by mouth on Day 1. After at least 48 hours, participants will take rabeprazole tablets by mouth once a day for 7 days. On the last (7th) day of rabeprazole dosing, another dose of sisunatovir tablets will be taken by mouth.
The study will look at the blood levels of sisunatovir with and without taking rabeprazole. This will help see how sisunatovir should be given in the future.
The total planned time of participation is about 10 to 11 weeks. The study consists of:
* screening period of up to 28 days before taking sisunatovir. * 13 days of staying in the study clinic. * a follow-up contact that will occur 28 to 35 days after taking sisunatovir the last time.
Looking for future studies?
Notify Me18 year and older
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
Single Dose
Tablets once daily for 7 days
Tablets once daily for 7 days
Tablets once daily for 7 days
Time frame: 0 to 72 hour postdose
Time frame: 0 to 72 hours postdose
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Time frame: 0 to 72 hours postdose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: Baseline up to 35 days after last dose of study intervention
Time frame: Baseline to Study Day 12 (Part 1) or Study Day 20 (Part 2)
Time frame: Baseline to Study Day 12 (Part 1) or Study Day 20 (Part 2)
Pfizer
Industry
A PHASE 1, OPEN-LABEL, TWO-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE EFFECT OF A PROTON PUMP INHIBITOR ON THE PHARMACOKINETICS OF SISUNATOVIR IN 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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