Estimation of the Effect of Multiple Dose Ritlecitinib (PF-06651600) on the Pharmacokinetics of a Single Dose of Caffeine in Healthy Participants

• ClinicalTrials.gov Identifier: NCT04655040
• Recruitment Status: Completed
• First Posted: December 4, 2020
• Last Update Posted: March 18, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Healthy Participants	Drug: Caffeine; Other: Ritlecitinib	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: December 18, 2020
• Actual Primary Completion Date: March 5, 2021
• Actual Study Completion Date: March 5, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: Caffeine and Ritlecitinib; 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.

Drug: Caffeine; 100milligram (mg) tablet taken orally in period 1 and period 2; Other: Ritlecitinib; 200 milligrams (mg) taken orally once a day(QD) for 8 days; Other Name: PF-06651600

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Incidence of treatment-emergent adverse events [ Time Frame: Baseline through Day 28 ]
2. Incidence of clinically significant abnormalities in vital signs [ Time Frame: Baseline through Day 11 ]
3. Incidence of clinically significant abnormalities in clinical laboratory values [ Time Frame: Baseline through Day 11 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

-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).
• 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.

Contacts and Locations

Locations

United States, Connecticut

New Haven Clinical Research Unit

New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04655040
• Other Study ID Numbers: B7981054
• First Posted: December 4, 2020
• Last Update Posted: March 18, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: 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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Caffeine; Central Nervous System Stimulants; Physiological Effects of Drugs; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Purinergic P1 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents