A PHASE I, OPEN LABEL, FIXED SEQUENCE STUDY TO EVALUATE THE STEADY STATE PHARMACOKINETIC DRUG-DRUG INTERACTION BETWEEN PF-06650833 AND PF-06651600 IN HEALTHY ADULT PARTICIPANTS
Overview
- Phase
- Phase 1
- Intervention
- PF-06650833 alone
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- PF-06651600 AUCtau
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the potential pharmacokinetic (PK) drug-drug interaction (DDI) between PF-06650833 and PF-06651600 in healthy adult participants.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD)
- •Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, including blood pressure (BP) and pulse rate measurement, temperature, 12-lead ECG, and laboratory tests.
- •Participants who are 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).
- •Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.
Exclusion Criteria
- •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).
- •Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- •Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
- •Infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.
- •Participants with any of the protocol-listed acute or chronic infections or infection history.
- •History of febrile illness within 5 days prior to the first dose of investigational product (in both Periods).
- •History of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
- •Participants have a known present 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.
- •Benign ethnic (cyclic) neutropenia.
- •Having received any live (attenuated) vaccines within 6 weeks prior to the first dose of investigational product.
Arms & Interventions
Single arm
The study will have only one study group in a fixed-sequence type of design with two periods
Intervention: PF-06650833 alone
Single arm
The study will have only one study group in a fixed-sequence type of design with two periods
Intervention: PF-06651600 alone
Single arm
The study will have only one study group in a fixed-sequence type of design with two periods
Intervention: PF-06650833 together with PF-06651600
Outcomes
Primary Outcomes
PF-06651600 AUCtau
Time Frame: Fold-change from Period 2/Day 7 to Period 2/Day 12
Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.
PF-06651600 Cmax
Time Frame: Fold-change from Period 2/Day 7 to Period 2/Day 12
Maximum observed concentration (Cmax) derived from plasma
PF-06650833 AUCtau
Time Frame: Fold-change from Period 1/Day 5 to Period 2/Day 12
Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.
PF-06650833 Cmax
Time Frame: Fold-change from Period 1/Day 5 to Period 2/Day 12
Maximum observed concentration (Cmax) derived from plasma
Secondary Outcomes
- Percentage of participants with treatment emergent adverse events(From screening until follow-up phone call that takes place 28-35 days after last study dose (total period of approximately 87 days))
- Percentage of participants with clinical laboratory test results above/below certain threshold(At screening; Days -1, 6 in Period 1; and Days -1, 8, 9, 11, 13 in Period 2)
- Percentage of participants with vital signs above/below certain threshold(At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2)
- Percentage of participants with 12-lead electrocardiogram (ECG) results above/below certain threshold(At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2)