A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS

NCT03827668 | Completed Phase 1 FDA Drug

• 1 other identifier: B7921028
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Drug-Drug Interaction

Outcome Measures

Primary Outcomes (4)

• PF-06650833 Cmax

  Maximum observed concentration (Cmax) derived from plasma

  Fold-change from Period 1/Day 5 to Period 2/Day 12

• PF-06650833 AUCtau

  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.

  Fold-change from Period 1/Day 5 to Period 2/Day 12

• PF-06651600 Cmax

  Maximum observed concentration (Cmax) derived from plasma

  Fold-change from Period 2/Day 7 to Period 2/Day 12

• PF-06651600 AUCtau

  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.

  Fold-change from Period 2/Day 7 to Period 2/Day 12

Secondary Outcomes (4)

• 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

Study Arms (1)

Single arm

EXPERIMENTAL

The study will have only one study group in a fixed-sequence type of design with two periods

Drug: PF-06650833 alone; Drug: PF-06651600 alone; Drug: PF-06650833 together with PF-06651600

Interventions

PF-06650833 alone DRUG

In Period 1, Days 1-5, participants will receive PF-06650833 once daily alone.

Single arm

PF-06651600 alone DRUG

In Period 2, Days 1-7, participants will receive PF-06651600 once daily alone.

Single arm

PF-06650833 together with PF-06651600 DRUG

In Period 2, Days 8-12, participants will receive PF-06650833 once daily together with PF-06650833 once daily.

Single arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
• Previous administration of an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of investigational product used in this study.
• Known participation in a clinical trial of PF-06650833 or PF-06651600.
• A positive urine drug test at screening or admission.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Interventions

1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide; PF-06651600

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase I, open label, fixed sequence study. The study will consist of 2 periods in a single fixed sequence. In Period 1, participants will receive PF-06650833 once daily on Days 1-5 and PF-06650833 PK will be assessed for 24 hours following Day 5 dosing. Participants will be discharged on Day 6 after completion of study related activities. There will be a washout period of at least 7 days between last dosing in Period 1 and first dosing in Period 2. In Period 2, participants will receive PF-06651600 once daily alone on Days 1-7, and PF-06651600 once daily together with PF-06650833 once daily on Days 8-12. PF-06651600 PK will be assessed for 24 hours following Day 7 dosing, while PK for both PF-06651600 and PF-06650833 will be assessed for 24 hours following Day 12 dosing. Across both periods few additional pre-dose (trough) PK samples will be collected. Participants will remain in the unit up to Day 13 when they will be discharged after completion of study related activities.

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 1, 2019
• Study Start: February 7, 2019
• Primary Completion: April 29, 2019
• Study Completion: April 29, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)