Healthy ParticipantsPhase 1NCT03916393
PF-06651600 Taste Study.
A Phase 1 study testing PF-06651600 20 mg and Bitrex solution in people with Healthy Participants, run by Pfizer at 1 site in Belgium.
Trial summary
This is a single-blind, randomized, five (5)-period, cross-over study in healthy adult participants. A group of approximately 10 participants will assess the sensory attributes (taste and palatability) of 4 different formulations of an investigational product (PF-06651600 active pharmaceutical ingredient) and Bitrex… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- PF-06651600 20 mg and Bitrex solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Apr 2019to 10 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease Infection with Hepatitis B, C or HIV
- Participants with conditions that affect their ability to taste
- Participants who currently smoke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A SINGLE BLIND, RANDOMIZED, CROSS-OVER STUDY IN HEALTHY ADULT PARTICIPANTS TO INVESTIGATE THE PALATABILITY OF ORAL FORMULATIONS OF PF-06651600 FOR PEDIATRIC USE
This is a single-blind, randomized, five (5)-period, cross-over study in healthy adult participants. A group of approximately 10 participants will assess the sensory attributes (taste and palatability) of 4 different formulations of an investigational product (PF-06651600 active pharmaceutical ingredient) and Bitrex (Registered) positive control in a specified sequence in 1 day.
- Conditions
- Healthy Participants
- Being tested
- PF-06651600 20 mg, Bitrex solution
- Keywords
- PF-06651600, Palatability, Bitrex, Taste Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06651600 20 mgDrug
PF-06651600 in four (4) different oral formulations will be administered in different periods.
Bitrex solutionOther
Bitrex solution at 0.5 ppm will be included in the treatment sequence together with the four PF-06651600 formulations.
| Study group | Role | What they receive |
|---|---|---|
| PF-06651600 Treatment A | Experimental | Active pharmaceutical ingredient (API)solution in water Receives: Drug: PF-06651600 20 mg |
| PF-06651600 Treatment B | Experimental | API in sweetened solution Receives: Drug: PF-06651600 20 mg |
| PF-06651600 Treatment C | Experimental | API blend suspension in water Receives: Drug: PF-06651600 20 mg |
| PF-06651600 Treatment D | Experimental | API blend suspension in apple sauce Receives: Drug: PF-06651600 20 mg |
| Bitrex (Registered) Treatment E | Other | Positive control for bitterness Receives: Other: Bitrex solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting overall liking of drug formulation
Overall liking assesses the degree that a participant likes a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Measured: Baseline through 20 minutes post dose
Percentage of subjects reporting overall liking of drug formulation
Overall liking assesses the degree that a participant likes a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Measured: Baseline through 20 minutes post dose
Number of subjects reporting saltiness of drug formulation
Saltiness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Measured: Baseline through 20 minutes post dose
Percentage of subjects reporting saltiness of drug formulation
Saltiness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Measured: Baseline through 20 minutes post dose
Number of subjects reporting bitterness of drug formulation
Bitterness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Measured: Baseline through 20 minutes post dose
Percentage of subjects reporting bitterness of drug formulation
Bitterness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Measured: Baseline through 20 minutes post dose
Number of subjects reporting mouth feel of drug formulation
Mouth feel assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Measured: Baseline through 20 minutes post dose
Percentage of subjects reporting mouth feel of drug formulation
Mouth feel assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Measured: Baseline through 20 minutes post dose
Number of subjects reporting sourness of drug formulation
Sourness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Measured: Baseline through 20 minutes post dose
Percentage of subjects reporting sourness of drug formulation
Sourness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Measured: Baseline through 20 minutes post dose
Number of subjects reporting tongue/mouth burn from drug formulation
Tongue/mouth burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Measured: Baseline through 20 minutes post dose
Percentage of subjects reporting tongue/mouth burn from drug formulation
Tongue/mouth burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Measured: Baseline through 20 minutes post dose
Number of subjects reporting formulation preference
Formulation preference assesses the degree that a participant prefers a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Measured: Baseline through 20 minutes post dose
Percentage of subjects reporting formulation preference
Formulation preference assesses the degree that a participant prefers a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Measured: Baseline through 20 minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start15 Apr 2019
- Primary completion10 May 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916393
- Sponsor's protocol ID
- B7981021
- Other IDs
- 2019-000108-13, 2019
- Status last verified
- Jun 2019
- First submitted
- 12 Apr 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SINGLE BLIND, RANDOMIZED, CROSS-OVER STUDY IN HEALTHY ADULT PARTICIPANTS TO INVESTIGATE THE PALATABILITY OF ORAL FORMULATIONS OF PF-06651600 FOR PEDIATRIC USE
- ClinicalTrials.gov ID
- NCT03916393
- Acronym / sponsor ID
- B7981021
- Conditions
- Healthy Participants
- Keywords
- PF-06651600, Palatability, Bitrex, Taste Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-blind, randomized, five (5)-period, cross-over study in healthy adult participants. A group of approximately 10 participants will assess the sensory attributes (taste and palatability) of 4 different formulations of an investigational product (PF-06651600 active pharmaceutical ingredient) and Bitrex (Registered) positive control in a specified sequence in 1 day.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PF-06651600 Treatment A | Experimental | Drug: PF-06651600 20 mgActive pharmaceutical ingredient (API)solution in water |
| PF-06651600 Treatment B | Experimental | Drug: PF-06651600 20 mgAPI in sweetened solution |
| PF-06651600 Treatment C | Experimental | Drug: PF-06651600 20 mgAPI blend suspension in water |
| PF-06651600 Treatment D | Experimental | Drug: PF-06651600 20 mgAPI blend suspension in apple sauce |
| Bitrex (Registered) Treatment E | Other | Other: Bitrex solutionPositive control for bitterness |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease Infection with Hepatitis B, C or HIV
- Participants with conditions that affect their ability to taste
- Participants who currently smoke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-06651600 20 mgPF-06651600 in four (4) different oral formulations will be administered in different periods. | Drug | PF-06651600 Treatment A, PF-06651600 Treatment B, PF-06651600 Treatment C, PF-06651600 Treatment D |
| Bitrex solutionBitrex solution at 0.5 ppm will be included in the treatment sequence together with the four PF-06651600 formulations. | Other | Bitrex (Registered) Treatment E |
Primary outcome
Number of subjects reporting overall liking of drug formulation
Time frame: Baseline through 20 minutes post dose
Overall liking assesses the degree that a participant likes a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Percentage of subjects reporting overall liking of drug formulation
Time frame: Baseline through 20 minutes post dose
Overall liking assesses the degree that a participant likes a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Number of subjects reporting saltiness of drug formulation
Time frame: Baseline through 20 minutes post dose
Saltiness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Percentage of subjects reporting saltiness of drug formulation
Time frame: Baseline through 20 minutes post dose
Saltiness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Number of subjects reporting bitterness of drug formulation
Time frame: Baseline through 20 minutes post dose
Bitterness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Percentage of subjects reporting bitterness of drug formulation
Time frame: Baseline through 20 minutes post dose
Bitterness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Number of subjects reporting mouth feel of drug formulation
Time frame: Baseline through 20 minutes post dose
Mouth feel assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Percentage of subjects reporting mouth feel of drug formulation
Time frame: Baseline through 20 minutes post dose
Mouth feel assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Number of subjects reporting sourness of drug formulation
Time frame: Baseline through 20 minutes post dose
Sourness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Percentage of subjects reporting sourness of drug formulation
Time frame: Baseline through 20 minutes post dose
Sourness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Number of subjects reporting tongue/mouth burn from drug formulation
Time frame: Baseline through 20 minutes post dose
Tongue/mouth burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Percentage of subjects reporting tongue/mouth burn from drug formulation
Time frame: Baseline through 20 minutes post dose
Tongue/mouth burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire
Number of subjects reporting formulation preference
Time frame: Baseline through 20 minutes post dose
Formulation preference assesses the degree that a participant prefers a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Percentage of subjects reporting formulation preference
Time frame: Baseline through 20 minutes post dose
Formulation preference assesses the degree that a participant prefers a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06651600 20 mg and Bitrex solution in people with Healthy Participants, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects reporting overall liking of drug formulation (time frame: Baseline through 20 minutes post dose). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.