Osivelotor
DrugA medicine to treat sickle cell disease.
Other names: PF-07940367
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 1
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:
This study is seeking participants who are:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A medicine to treat sickle cell disease.
Other names: PF-07940367
Famotidine is a marketed medicine which decreases the amount of acid made in the stomach and is used to prevent and treat heartburn.
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 ").
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").
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").
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").
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.
Time frame: Day 1 to 28
Time frame: Day 1 to 84
Time frame: Day 1 to Day 2 for Part 1, Day 1 to Day 7 for Part 2.
Time frame: Day 1 and Day 2
Time frame: Day 1 and Day 7
Time frame: Day 1 and Day 2
Time frame: Day 1, 2 and Day 7
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
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)
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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