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

NCT06507904 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: C53510092024-511410-20-00
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Keywords

palatability; bioavailability

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• 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

Study Arms (11)

Part 1 Sequence 1 - Palatability

EXPERIMENTAL

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

Part 1 Sequence 2 - Palatability

EXPERIMENTAL

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

Part 1 Sequence 3 - Palatability

EXPERIMENTAL

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

Part 1 Sequence 4 - Palatability

EXPERIMENTAL

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

Part 2 Pharmacokinetics - Treatment E

EXPERIMENTAL

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

Part 2 Pharmacokinetics - Treatment F

EXPERIMENTAL

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

Part 2 Pharmacokinetics - Treatment G

EXPERIMENTAL

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

Part 2 Pharmacokinetics - Treatment H

EXPERIMENTAL

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

Part 2 Pharmacokinetics - Treatment I

EXPERIMENTAL

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

Part 2 Pharmacokinetics - Treatment J

EXPERIMENTAL

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

Part 2 Pharmacokinetics - Treatment K

EXPERIMENTAL

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

Osivelotor DRUG

A medicine to treat sickle cell disease.

Also known as: PF-07940367

Part 1 Sequence 1 - Palatability; Part 1 Sequence 2 - Palatability; Part 1 Sequence 3 - Palatability; Part 1 Sequence 4 - Palatability; Part 2 Pharmacokinetics - Treatment E; Part 2 Pharmacokinetics - Treatment F; Part 2 Pharmacokinetics - Treatment G; Part 2 Pharmacokinetics - Treatment H; Part 2 Pharmacokinetics - Treatment I; Part 2 Pharmacokinetics - Treatment J; Part 2 Pharmacokinetics - Treatment K

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.

Part 2 Pharmacokinetics - Treatment H

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Interventions

Famotidine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): February 12, 2027
• Study Completion (Estimated): May 3, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share