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

Launched by PFIZER · Jul 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Osivelotor to see how its taste and how well it gets into the blood when taken with food, liquids, or an antacid. The trial is designed for healthy adults aged 18 to 65 years. To join the study, participants need to be in good health, which means they shouldn’t have any serious medical conditions or be taking certain medications that could affect the results. Additionally, they must meet specific health criteria, like having a certain body weight and body mass index (BMI).

If you participate in this trial, you can expect to undergo a thorough health check-up before starting, including a physical exam and some lab tests. The study will not be recruiting participants just yet, but once it starts, it will provide valuable information about how Osivelotor works with different foods and medications. This could help doctors understand the best ways to use this medication in the future.

Gender

ALL

Eligibility criteria

• 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.