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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511410-20-00 | Registry Identifier | CTIS (EU) |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Sequence 1 - Palatability | Experimental | Participants will receive 4 preparations (Treatments A, B, C, D) of osivelotor pellet/granules at least 2 hours apart on Day 1 which they will put in their mouth and then spit it out. |
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| Part 1 Sequence 2 - Palatability | Experimental | Participants will receive 4 preparations (Treatments B, C, D, A) of osivelotor pellet/granules at least 2 hours apart on Day 1 which they will put in their mouth and then spit it out. |
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| Part 1 Sequence 3 - Palatability | Experimental | Participants will receive 4 preparations (Treatments C, D, A, B) of osivelotor pellet/granules at least 2 hours apart on Day 1 which they will put in their mouth and then spit it out. |
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| Part 1 Sequence 4 - Palatability | Experimental | Participants will receive 4 preparations (Treatments D, A, B, C) of osivelotor pellet/granules at least 2 hours apart on Day 1 which they will put in their mouth and then spit it out. |
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| Part 2 Pharmacokinetics - Treatment E | Experimental | Participants will receive 1 preparation (Treatment E) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osivelotor | Drug | A medicine to treat sickle cell disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Part 2 Pharmacokinetics - Treatment F | Experimental | Participants will receive 1 preparation (Treatment F) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow. They might have a dose on Day 7 which they will put in their mouth and then spit it out; afterwards they will complete the taste questionnaire. |
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| Part 2 Pharmacokinetics - Treatment G | Experimental | Participants will receive 1 preparation (Treatment G) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow. |
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| Part 2 Pharmacokinetics - Treatment H | Experimental | Participants will receive famotidine and afterwards preparation (Treatment H) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow. |
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| Part 2 Pharmacokinetics - Treatment I | Experimental | Participants will receive 1 preparation (Treatment I) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow. |
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| Part 2 Pharmacokinetics - Treatment J | Experimental | Participants will receive 1 preparation (Treatment J) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow. They might have a dose on Day 7 which they will put in their mouth and then spit it out; afterwards they will complete the taste questionnaire. |
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| Part 2 Pharmacokinetics - Treatment K | Experimental | Participants will receive 1 preparation (Treatment K) of osivelotor pellet/granules on Day 1 which they will put in their mouth and swallow. |
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| Famotidine | Other | Famotidine is a marketed medicine which decreases the amount of acid made in the stomach and is used to prevent and treat heartburn. |
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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. |
| 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144 hours post-dose |
| 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |