- AREAS OF RESEARCH
- GET CONNECTED
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.
Closest Location
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.
Condition
SARS-CoV-2 Infections
Sex
Male or Female
Age
18 - 75 years