NCT06003829

A Study to Learn About the Tastes of Different Suspensions With the Study Medicine (PF-07923568) in Healthy Adult Participants.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sinsunatovir	Single dose, to be spit out after tasting
OTHER	Bitrex	Single dose, to be spit out after tasting

Timeline

• Start date: 2023-07-31
• Primary completion: 2023-09-20
• Completion: 2023-09-20
• First posted: 2023-08-22
• Last updated: 2024-11-13
• Results posted: 2024-11-13

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study