Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
NCT Number: NCT06693518
This is a Phase 1, open-label, randomized, 2-period, 2-sequence, cross-over study to estimate the effect of ibuzatrelvir on the PK of dabigatran, a P-gp substrate, in healthy adult participants. Participants who discontinue from the study for non-safety reasons may be replaced at the Sponsor's discretion in collaboration with the investigator.
Healthy participants will be screened to determine eligibility within 28 days prior to study treatment. Participants will report to the CRU on Period 1 Day -1 in Period 1 and will be required to stay at the CRU until discharge Day 3 in Period 2.
This study will consist of two treatments. Treatment A: 150 mg of dabigatran etexilate; Treatment B: ibuzatrelvir 600 mg + 150 mg of dabigatran etexilate. The participants will be fasted overnight for at least 10 hours before administration of study intervention. Serial dabigatran samples will be collected up to 48 hours post-dose in both Period 1 and Period 2. Dosing of dabigatran in Period 1 and 2 will be separated by approximately 72h.
A follow-up (which may be a phone call) will be made to participants approximately 28 to 35 days from administration of the final dose of study intervention.
Approximately 20 participants will be enrolled in the study. PK samples will be collected for Dabigatran and Ibuzatrelvir as per SOA.
Looking for future studies?
Notify Me18 year–75 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
AST or ALT ≥1.5 × ULN Total bilirubin ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ≤ ULN PT/INR or PTT/aPTT >1.0 × ULN
Ibuzatrelvir 600 mg + Dabigatran Etexilate 150 mg
Dabigatran Etexilate 150 mg
Time frame: 0 - 48 hours
Plasma Cmax (Maximum observed concentration) of Dabigatran with ibuzatrelvir (Test) versus without ibuzatrelvir (Reference)
Time frame: 0 - 48 hours
Plasma AUCinf of Dabigatran with ibuzatrelvir (Test) versus without ibuzatrelvir (Reference)
Time frame: Day 1 till follow up visit (Day 28-35)
Time frame: Day 1 till follow up visit (Day 28-35)
Time frame: Day 1 till follow up visit (Day 28-35)
Pfizer
Industry
A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO ESTIMATE THE EFFECT OF IBUZATRELVIR ON THE PHARMACOKINETICS OF DABIGATRAN 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.
Published trials that share one or more normalized conditions with this study.
NCT04303299
COVID-19, Coronaviridae Infections
Bangkok, Thailand
View Trial DetailsNCT05278390
COVID-19, Coronaviridae Infections
Nancy, France
View Trial DetailsNCT04794829
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial DetailsNCT07552779
COVID-19, COVID-19 (Coronavirus Disease 2019)
Brussels, Bruxelles-capitale, Région de, Belgium
View Trial Details