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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Osivelotor; Other: Famotidine

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and female participants aged 18 years (or the minimum age of consent in accordance with local regulations if >18 years) to 65 years (inclusive) at screening who are overtly healthy as determined by medical evaluation including a detailed medical history, complete physical examination (PE), including blood pressure (BP) and pulse rate (PR) measurement, 12-lead ECG (electrocardiogram) and clinical laboratory tests.
• Body mass index (BMI) of ≥16 to ≤32 kg/m2; Body weight ≥50 kg (110 lb).

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Use of prescription or nonprescription drug, dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer), with the exception of moderate or strong cytochrome P450 (CYP)3A inducers or inhibitors which are prohibited within 14 days plus 5 half-lives, prior to the first dose of study intervention.
• Current use of any prohibited concomitant medication(s) or participant unwilling/able to use a permitted concomitant medication(s).
• Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
• For females, pregnancy, as indicated by a positive serum pregnancy test (serum) at screening and/or a positive pregnancy test (serum and/or urine) on Day -1 in women of childbearing potential.
• Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest.
• Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF [QTc corrected using Fridericia's formula] >450 ms, complete left bundle branch block (LBBB), signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree AV (atrioventricular) block, or serious bradyarrhythmias or tachyarrhythmias).
• Participants with defined abnormalities in kidney and liver laboratory tests at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Sequence 1 - Palatability; Participants will receive 4 preparations (Treatments A, B, C, D) of osivelotor pellet/granules at least 2 hours apart on Day 1 which they will put in their mouth and then spit it out.	Drug: Osivelotor; A medicine to treat sickle cell disease.; Other Names: PF-07940367
Experimental: Part 1 Sequence 2 - Palatability; Participants will receive 4 preparations (Treatments B, C, D, A) of osivelotor pellet/granules at least 2 hours apart on Day 1 which they will put in their mouth and then spit it out.	Drug: Osivelotor; A medicine to treat sickle cell disease.; Other Names: PF-07940367
Experimental: Part 1 Sequence 3 - Palatability; Participants will receive 4 preparations (Treatments C, D, A, B) of osivelotor pellet/granules at least 2 hours apart on Day 1 which they will put in their mouth and then spit it out.	Drug: Osivelotor; A medicine to treat sickle cell disease.; Other Names: PF-07940367
Experimental: Part 1 Sequence 4 - Palatability; Participants will receive 4 preparations (Treatments D, A, B, C) of osivelotor pellet/granules at least 2 hours apart on Day 1 which they will put in their mouth and then spit it out.	Drug: Osivelotor; A medicine to treat sickle cell disease.; Other Names: PF-07940367
Experimental: Part 2 Pharmacokinetics - Treatment E; Participants will receive 1 preparation (Treatment E) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow.	Drug: Osivelotor; A medicine to treat sickle cell disease.; Other Names: PF-07940367
Experimental: Part 2 Pharmacokinetics - Treatment F; Participants will receive 1 preparation (Treatment F) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow. They might have a dose on Day 7 which they will put in their mouth and then spit it out; afterwards they will complete the taste questionnaire.	Drug: Osivelotor; A medicine to treat sickle cell disease.; Other Names: PF-07940367
Experimental: Part 2 Pharmacokinetics - Treatment G; Participants will receive 1 preparation (Treatment G) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow.	Drug: Osivelotor; A medicine to treat sickle cell disease.; Other Names: PF-07940367
Experimental: Part 2 Pharmacokinetics - Treatment H; Participants will receive famotidine and afterwards preparation (Treatment H) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow.	Drug: Osivelotor; A medicine to treat sickle cell disease.; Other Names: PF-07940367; 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.
Experimental: Part 2 Pharmacokinetics - Treatment I; Participants will receive 1 preparation (Treatment I) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow.	Drug: Osivelotor; A medicine to treat sickle cell disease.; Other Names: PF-07940367
Experimental: Part 2 Pharmacokinetics - Treatment J; Participants will receive 1 preparation (Treatment J) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow. They might have a dose on Day 7 which they will put in their mouth and then spit it out; afterwards they will complete the taste questionnaire.	Drug: Osivelotor; A medicine to treat sickle cell disease.; Other Names: PF-07940367
Experimental: Part 2 Pharmacokinetics - Treatment K; Participants will receive 1 preparation (Treatment K) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow.	Drug: Osivelotor; A medicine to treat sickle cell disease.; Other Names: PF-07940367

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Mouth Feel Effect	Mouth feel visual analogue scale (VAS) assesses the participant's global perception of mouth feel (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 points to 100 points (0 points = " Bad Mouth feel ", 50 points = "neither bad nor good mouth feel", and 100 points = "Good Mouth feel ").	1, 5, 10, 20 minutes post dose
Part 1: Bitter effect	Bitter visual analogue scale (VAS) assesses the participant's global perception of bitterness (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 points to 100 points (0 points = " extremely bitter ", 50 points = "neither bad nor good bitterness", and 100 points = "not bitter").	1, 5, 10, 20 minutes post dose
Part 1: Tongue/mouth burn effect	Tongue/mouth burn visual analogue scale (VAS) assesses the participant's global perception of tongue/mouth burn (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 points to 100 points (0 points = "extreme burn", 50 points = "neither bad nor good burn", and 100 points = "no burn").	1, 5, 10, 20 minutes post dose
Part 1:Overall liking effect	Overall liking visual analogue scale (VAS) assesses the participant's global perception of overall liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 points to 100 points (0 points = "bad", 50 points = "neither bad nor good", and 100 points = "good").	1, 5, 10, 20 minutes post dose
Part 2: Area under the Concentration-Time Curve (AUC 0-144) of osivelotor, as data permits	AUC from 0 to 144 hours is a measure of the whole blood concentration of the drug over time. It is used to characterize drug absorption; if AUC0-144 not available, then AUClast will be calculated.	0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of Participants With Treatment-Emergent Adverse Events (AEs)		Day 1 to 28
Part 2: Number of Participants With Treatment-Emergent Adverse Events (AEs)		Day 1 to 84
Part 1 and 2: Number of participants with clinically significant laboratory abnormalities.		Day 1 to Day 2 for Part 1, Day 1 to Day 7 for Part 2.
Part 1: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings		Day 1 and Day 2
Part 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings		Day 1 and Day 7
Part 1: Number of Participants With Clinically Significant With Clinically Significant Vital Signs		Day 1 and Day 2
Part 2: Number of Participants With Clinically Significant With Clinically Significant Vital Signs		Day 1, 2 and Day 7
Part 2: Maximum observed whole blood concentration (Cmax) of osivelotor pediatric formulation	Cmax is a measure of the highest whole blood concentration of the drug over time.	0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose
Part 2: Area under the Concentration-Time Curve (AUC last) of osivelotor	AUC from 0 hours to last value is a measure of the whole blood concentration of the drug over time. It is used to characterize drug absorption.	0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose
Part 2: Time (Tmax) to maximum observed whole blood concentration (Cmax) of osivelotor pediatric formulation	Tmax is a measure of the time it takes to get to the highest whole blood concentration of the drug over time.	0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose
Part 2: Maximum observed whole blood concentration (Cmax, dose normalized, if applicable) of osivelotor pediatric formulation	Cmax is a measure of the highest whole blood concentration of the drug over time.	0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose
Part 2: Area under the Concentration-Time Curve (AUC last, dose normalized, if applicable) of osivelotor	AUC from 0 hours to last value is a measure of the whole blood concentration of the drug over time. It is used to characterize drug absorption.	0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): February 12, 2027
• Study Completion (Estimated): May 3, 2027

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: bioavailability; palatability
• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Famotidine
• Other Study ID Numbers: C5351009; 2024-511410-20-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No