At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A RANDOMIZED, PHASE 1, SINGLE-BLIND, MULTI-PERIOD STUDY TO INVESTIGATE THE PALATABILITY OF PF-07923568 ORAL SUSPENSION IN DIFFERENT LIQUID VEHICLES IN HEALTHY ADULT PARTICIPANTS
In Brief
A Phase 1 clinical trial evaluating Sinsunatovir and Bitrex for Healthy. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is to learn about the tastes of different suspensions with the study medicine called PF-07923568 in healthy adult participants. In a suspension, the medicine is mixed with a liquid, usually water, in which it cannot dissolve and therefore remains intact in the form of small particles. This study is seeking for healthy participants who: * are aged 18 years of age or older. * can produce a baby must agree to use a highly effective method of birth control. * are confirmed to be healthy by some medical tests. This study can include both men and women. * have body mass index (BMI) of 16 to 32 kg/m2 and a total body weight of more than 45 kilograms. Participants will take sisunatovir prepared in 5 different suspensions and bitrex over two days to see if they are good to taste. Participants will answer a questionnaire after tasting each suspension. The questionnaire will be completed for each suspension. The questionnaire asks participants to test each suspension at 4 different times after tasting and spitting out the suspension. At least 60 minutes will pass between tasting each suspension. The total planned time period of participation is around 5 to 8 weeks. This includes the screening period of up to 28 days. Followed by first administration of study medicine. Then a 3 day in-patient stay at the study clinic. It also includes a follow-up phone call that happens 28-35 days after the final taste test.
Study Details
Timeline
Interventions
Single dose, to be spit out after tasting
Single dose, to be spit out after tasting