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.
NCT Number: NCT06507904
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Osivelotor|OTHER: Famotidine
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-13
Completion Date: 2025-02-26

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.

Primary Outcome Measures: 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 ")., 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")., 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")., 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")., 1, 5, 10, 20 minutes post dose|Part 2: Area under the Concentration-Time Curve (AUC 0-144) of osivelotor, as data permits, 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., 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose
Secondary Outcome Measures: Part 1: Number of Participants With Treatment-Emergent Adverse Events (AEs), Day 1 to 28|Part 2: Number of Participants With Treatment-Emergent Adverse Events (AEs), Day 1 to 84|Part 1 and 2: Number of participants with clinically significant laboratory abnormalities., 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, Day 1 and Day 2|Part 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings, Day 1 and Day 7|Part 1: Number of Participants With Clinically Significant With Clinically Significant Vital Signs, Day 1 and Day 2|Part 2: Number of Participants With Clinically Significant With Clinically Significant Vital Signs, 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., 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., 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., 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., 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., 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose