A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or … (NCT06507904) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
52 participantsStarted 2026-09-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
What they're measuring
1
Part 1: Mouth Feel Effect
Timeframe: 1, 5, 10, 20 minutes post dose
2
Part 1: Bitter effect
Timeframe: 1, 5, 10, 20 minutes post dose
3
Part 1: Tongue/mouth burn effect
Timeframe: 1, 5, 10, 20 minutes post dose
4
Part 1:Overall liking effect
Timeframe: 1, 5, 10, 20 minutes post dose
5
Part 2: Area under the Concentration-Time Curve (AUC 0-144) of osivelotor, as data permits