Taste and how osivelotor gets into the blood with or without food

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ThisPhase 1 study has two parts in healthy adults to explore taste and blood absorption of osivelotor (PF-07940367). Part 1 focuses on tasting the medicine administered in the mouth and spat out, with questionnaire feedback. Part 2 looks at how the medicine is absorbed when swallowed or held in the mouth, with and without an acid-reducing agent. The study will be conducted in a Pfizer clinical research unit in Brussels and includes safety monitoring and limited stay in the clinic. Eligible participants are adults 18–65 with BMI 16–32 kg/m2 and weight >50 kg, with screening assessments prior to dosing.

Why it matters

Who can join: the full rules

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

Where it's running

• Pfizer Clinical Research Unit - Brussels
  Brussels, Bruxelles-capitale, Région de, Belgium Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.