NCT06507904

A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Antacid in Healthy Adults

A Phase 1, Randomized, Crossover Design Study to Assess Palatability of Osivelotor (PF-07940367) Pediatric Formulations With Dosing Vehicle (Part 1) and Randomized, Single-Dose, Parallel Design Study to Estimate Relative Bioavailability of Osivelotor Pediatric Formulation With Dosing Vehicle and With Water Compared to Clinical Tablet Formulation, and Effect of Food and/or Acid-Reducing Agent On Bioavailability In Healthy Adult Participants (Part 2)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A study to learn how different preparations of Osivelotor taste and enter the blood with food or liquids, or with an antacid in healthy adults.

Detailed description

This study has two parts: Part 1 and Part 2. The purpose of Part 1 of this study is to learn how different preparations of the study medicine called osivelotor (PF-07940367) taste. The purpose of Part 2 of this study is to learn how the study medicine is taken up into the blood when mixed with: * soft foods or liquids given on an empty stomach or * with an acid-reducing agent in healthy adults. This study is seeking participants who are: * healthy females and males of 18 to 65 years of age. * have a body mass index of 16 to 32 kilogram per meter squared. * have a total body weight of more than 50 kilograms (110 pounds). Participants in Part 1 of the study will receive the study medicine 4 times with at least 2-hour interval on day one. This study medicine will not be swallowed but will be placed in the mouth and spat out. The participants will then complete a short questionnaire 4 times over 20 minutes. All study medicines will be given in the study clinic. Participants in Part 2 of the study will receive the study medicine up to 2 times. The first dose of the study medicine will be swallowed. The second dose the study medicine (if given) will not be swallowed but will be placed in the mouth and spat out for the taste questionnaire as above. All study medicines will be given in the study clinic. In Part 1, participants will be involved in this study for up to 2 months. During this time, there will be a two-day stay in the study clinic. After leaving the clinic, study team will also call participants once over the phone. Woman who could become pregnant may need to visit the study clinic instead of receiving a phone call. In Part 2, participants will be involved in this study for up to 4 months. During this time, there will be a seven-day stay in the study clinic. After leaving the clinic, the study team will also call participants 3 times over the phone. Woman who could become pregnant may need to visit the study clinic instead of receiving a phone calls. In both parts blood and urine tests will be done, and blood pressures and heart traces taken. Also, contraception requirements will need to be followed to prevent pregnancy during the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Osivelotor	A medicine to treat sickle cell disease.
OTHER	Famotidine	Famotidine is a marketed medicine which decreases the amount of acid made in the stomach and is used to prevent and treat heartburn.

Timeline

• Start date: 2026-09-15
• Primary completion: 2027-02-12
• Completion: 2027-05-03
• First posted: 2024-07-18
• Last updated: 2026-03-27

Regulatory

• FDA-regulated drug study