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Not yet recruitingNCT06507904Updated Sep 15, 2026

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 interventional study of Osivelotor and Famotidine in Healthy, sponsored by Pfizer. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Pfizer · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • palatability
  • bioavailability
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
  • Participants in Sub-Saharan Africa or who have relocated from Sub-Saharan Africa within 6 months of screening.
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
52 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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 · Other: Famotidine

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • DrugOsivelotor

    A medicine to treat sickle cell disease.

    Also known as: PF-07940367

  • OtherFamotidine

    Famotidine is a marketed medicine which decreases the amount of acid made in the stomach and is used to prevent and treat heartburn.

06

What researchers measure

Primary outcomes

  1. 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 ").

    Time frame: 1, 5, 10, 20 minutes post dose

  2. 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").

    Time frame: 1, 5, 10, 20 minutes post dose

  3. 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").

    Time frame: 1, 5, 10, 20 minutes post dose

  4. 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").

    Time frame: 1, 5, 10, 20 minutes post dose

  5. Part 2: Area under the Concentration-Time Curve (AUC 0-144) (if data permit, otherwise AUClast) for osivelotor in whole blood.

    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.

    Time frame: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose

  6. Part 2: Maximum observed whole blood concentration (Cmax) for osivelotor pediatric formulation in whole blood

    Cmax is a measure of the highest whole blood concentration of the drug over time.

    Time frame: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose

Secondary outcomes

  1. Part 1: Number of Participants With Treatment-Emergent Adverse Events (AEs)

    Time frame: Day 1 to 28

  2. Part 2: Number of Participants With Treatment-Emergent Adverse Events (AEs)

    Time frame: Day 1 to 84

  3. Part 1: Number of participants With Changes in laboratory assessments.

    Time frame: Day 1 to Day 2 for Part 1

  4. Part 2: Number of participants With Changes in laboratory assessments.

    Time frame: Day 1 to Day 7 for Part 2.

  5. Part 1: Number of Participants With Changes in Electrocardiograms (ECGs)

    Time frame: Day 1 and Day 2

  6. Part 2: Number of Participants With Changes in Electrocardiograms (ECGs)

    Time frame: Day 1 and Day 7

  7. Part 1: Number of Participants With Changes in Vital Signs

    Time frame: Day 1 and Day 2

  8. Part 2: Number of Participants With Changes in Vital Signs

    Time frame: Day 1, 2 and Day 7

  9. Part 2: Area under the Concentration-Time Curve (AUC last) for osivelotor pediatric formulation in whole blood.

    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.

    Time frame: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose

  10. Part 2: Maximum observed whole blood concentration (Cmax, dose normalized, if applicable) for osivelotor pediatric formulation in whole blood

    Cmax is a measure of the highest whole blood concentration of the drug over time.

    Time frame: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose

  11. Part 2: Area under the Concentration-Time Curve (AUC last, dose normalized, if applicable) for osivelotor pediatric formulation in whole blood

    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.

    Time frame: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose

  12. Part 2: Area under the Concentration-Time Curve (AUC0-144, dose normalized, if applicable) for osivelotor pediatric formulation in whole blood

    AUC from 0 hours to 144 hours after dosing is a measure of the whole blood concentration of the drug over that time period. It is used to characterize drug absorption.

    Time frame: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose

  13. Part 2: Time (Tmax) to maximum observed whole blood concentration (Cmax) for osivelotor pediatric formulation in whole blood

    Tmax is a measure of the time it takes to get to the highest whole blood concentration of the drug over time.

    Time frame: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06507904
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jul 18, 2024
Start date
Sep 22, 2026 (estimated)
Primary completion
Feb 19, 2027 (estimated)
Completion
May 10, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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