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.
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: * soft foods or liquids given on an empty stomach or * with an acid-reducing agent in healthy adults. This study is seeking participants who are: * healthy females and males of 18 to 65 years of age. * have a body mass index of 16 to 32 kilogram per meter squared. * have a total body weight of more than 50 kilograms (110 pounds). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
52
A medicine to treat sickle cell disease.
Famotidine is a marketed medicine which decreases the amount of acid made in the stomach and is used to prevent and treat heartburn.
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 ").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 1, 5, 10, 20 minutes post dose
Part 2: Area under the Concentration-Time Curve (AUC 0-144) of osivelotor, as data permits
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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: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose
Part 1: Number of Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: Day 1 to 28
Part 2: Number of Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: Day 1 to 84
Part 1 and 2: Number of participants with clinically significant laboratory abnormalities.
Time frame: 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
Time frame: Day 1 and Day 2
Part 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Time frame: Day 1 and Day 7
Part 1: Number of Participants With Clinically Significant With Clinically Significant Vital Signs
Time frame: Day 1 and Day 2
Part 2: Number of Participants With Clinically Significant With Clinically Significant Vital Signs
Time frame: Day 1, 2 and Day 7
Part 2: Maximum observed whole blood concentration (Cmax) of osivelotor pediatric formulation
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
Part 2: Area under the Concentration-Time Curve (AUC last) of osivelotor
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
Part 2: Time (Tmax) to maximum observed whole blood concentration (Cmax) of osivelotor pediatric formulation
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
Part 2: Maximum observed whole blood concentration (Cmax, dose normalized, if applicable) of osivelotor pediatric formulation
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
Part 2: Area under the Concentration-Time Curve (AUC last, dose normalized, if applicable) of osivelotor
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