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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osivelotor

Drug

A medicine to treat sickle cell disease.

Other names: PF-07940367

Famotidine

Other

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

Primary outcomes

  1. Part 1: Mouth Feel Effect

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

    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 ").

  2. Part 1: Bitter effect

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

    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").

  3. Part 1: Tongue/mouth burn effect

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

    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").

  4. Part 1:Overall liking effect

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

    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").

  5. Part 2: Area under the Concentration-Time Curve (AUC 0-144) of osivelotor, as data permits

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

    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.

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 and 2: Number of participants with clinically significant laboratory abnormalities.

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

  4. Part 1: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

    Time frame: Day 1 and Day 2

  5. Part 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

    Time frame: Day 1 and Day 7

  6. Part 1: Number of Participants With Clinically Significant With Clinically Significant Vital Signs

    Time frame: Day 1 and Day 2

  7. Part 2: Number of Participants With Clinically Significant With Clinically Significant Vital Signs

    Time frame: Day 1, 2 and Day 7

  8. Part 2: Maximum observed whole blood concentration (Cmax) of osivelotor pediatric formulation

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

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

  9. Part 2: Area under the Concentration-Time Curve (AUC last) of osivelotor

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

    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.

  10. Part 2: Time (Tmax) to maximum observed whole blood concentration (Cmax) of osivelotor pediatric formulation

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

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

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

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

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

  12. Part 2: Area under the Concentration-Time Curve (AUC last, dose normalized, if applicable) of osivelotor

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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