Healthy ParticipantsPhase 1NCT04655040
Estimation of the Effect of Multiple Dose Ritlecitinib (PF-06651600) on the Pharmacokinetics of a Single Dose of Caffeine in Healthy Participants
A Phase 1 study testing Caffeine and Ritlecitinib in people with Healthy Participants, run by Pfizer at 1 site in United States.
Trial summary
This will be a Phase 1, 2 period, fixed sequence, multiple-dose, open-label study of the effect of ritlecitinib on caffeine PK in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Caffeine and Ritlecitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 5 Mar 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.
- -BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). -
- Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
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- History of febrile illness within 5 days prior to the first dose of investigational product.
- History of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
- Known presence or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Participants who, according to the information provided on Drugs.com, would be at increased safety risk if dosed with caffeine.
- History of hypersensitivity to caffeine.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, 2-PERIOD, FIXED-SEQUENCE, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECTS OF RITLECITINIB (PF-06651600) ON THE PHARMACOKINETICS OF A SINGLE DOSE OF CAFFEINE IN HEALTHY PARTICIPANTS
This will be a Phase 1, 2 period, fixed sequence, multiple-dose, open-label study of the effect of ritlecitinib on caffeine PK in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study.
- Conditions
- Healthy Participants
- Being tested
- Caffeine, Ritlecitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
100milligram (mg) tablet taken orally in period 1 and period 2
RitlecitinibOther
Also called PF-06651600
200 milligrams (mg) taken orally once a day(QD) for 8 days
| Study group | Role | What they receive |
|---|---|---|
| Caffeine and Ritlecitinib | Experimental | In Period 1 Day 1, participants will be dosed with a single oral administration of caffeine 100 milligram (mg) tablet.
In Period 2 Day 1 to Day 7, participants will be dosed with a single oral administration of ritlecitinib 200 milligram (mg) tablet. On Day 8, participants will be dosed with caffeine 100 milligram (mg) tablet within 5 minutes after administration of a 200 milligram (mg) dose of ritlecitinib on the morning of Day 8. Dosing with oral 200 milligram (mg) ritlecitinib QD will continue until Day 9. Receives: Drug: Caffeine; Other: Ritlecitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) of caffeine
Measured: Day1 and Day8: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24. Day 8: Hour 36 and 48
Secondary outcomes (3)
Incidence of treatment-emergent adverse events
Measured: Baseline through Day 28
Incidence of clinically significant abnormalities in vital signs
Measured: Baseline through Day 11
Incidence of clinically significant abnormalities in clinical laboratory values
Measured: Baseline through Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start18 Dec 2020
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT04655040
- Sponsor's protocol ID
- B7981054
- Status last verified
- Mar 2021
- First submitted
- 3 Dec 2020
- Last updated
- 18 Mar 2021
- 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 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, 2-PERIOD, FIXED-SEQUENCE, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECTS OF RITLECITINIB (PF-06651600) ON THE PHARMACOKINETICS OF A SINGLE DOSE OF CAFFEINE IN HEALTHY PARTICIPANTS
- ClinicalTrials.gov ID
- NCT04655040
- Acronym / sponsor ID
- B7981054
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 4 Dec 2020 (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 will be a Phase 1, 2 period, fixed sequence, multiple-dose, open-label study of the effect of ritlecitinib on caffeine PK in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caffeine and Ritlecitinib | Experimental | Drug: Caffeine, Other: RitlecitinibIn Period 1 Day 1, participants will be dosed with a single oral administration of caffeine 100 milligram (mg) tablet. In Period 2 Day 1 to Day 7, participants will be dosed with a single oral administration of ritlecitinib 200 milligram (mg) tablet. On Day 8, participants will be dosed with caffeine 100 milligram (mg) tablet within 5 minutes after administration of a 200 milligram (mg) dose of ritlecitinib on the morning of Day 8. Dosing with oral 200 milligram (mg) ritlecitinib QD will continue until Day 9. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- -Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.
- -BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). -
- Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Caffeine100milligram (mg) tablet taken orally in period 1 and period 2 | Drug | Caffeine and Ritlecitinib |
| RitlecitinibAlso: PF-06651600200 milligrams (mg) taken orally once a day(QD) for 8 days | Other | Caffeine and Ritlecitinib |
Primary outcome
Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) of caffeine
Time frame: Day1 and Day8: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24. Day 8: Hour 36 and 48
3 secondary outcomes
Incidence of treatment-emergent adverse events
Time frame: Baseline through Day 28
Incidence of clinically significant abnormalities in vital signs
Time frame: Baseline through Day 11
Incidence of clinically significant abnormalities in clinical laboratory values
Time frame: Baseline through Day 11
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 18 Mar 2021.
- 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 Caffeine and Ritlecitinib in people with Healthy Participants, run by Pfizer at 1 site in United States.
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 12 inclusion and 0 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 18 Mar 2021. 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 United States. 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?
Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) of caffeine (time frame: Day1 and Day8: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24. Day 8: Hour 36 and 48). 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 18 Mar 2021.