A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, 2-WAY CROSSOVER STUDY ASSESSING PHARMACOKINETIC COMPARABILITY OF TWO PF-06881894 PRESENTATIONS, ON-BODY INJECTOR AND PREFILLED SYRINGE, IN HEALTHY PARTICIPANTS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- Pfizer
- Enrollment
- 141
- Locations
- 4
- Primary Endpoint
- Maximum Serum Concentration (Cmax) of PF-06881894
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This will be an open-label, randomized, 2-treatment, 2-period, crossover single-dose study in approximately 134 healthy adult participants. Participants will be randomized into 2 sequences of treatment as described in the following table of Intervention Groups and Duration.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and/or female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
- •Participants will include healthy individuals, with healthy being defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including BP and PR measurement, 12-lead ECG, chest X-ray, or clinical laboratory tests.
- •Participants agree to abstain from the use of tobacco- or nicotine-containing products for at least 90 days prior to dosing and have a negative urine screen for cotinine at Screening.
- •Participants agree to abstain from alcohol consumption for at least 48 hours prior to Day 1 of dosing in each study period and have a negative screen for alcohol.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •BMI between 19 and 30 kg/m2, inclusive, and body weight of not\<50 kg or \>100 kg.
- •Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Any condition possibly affecting drug absorption (eg, injuries to subcutaneous tissue at the injection site).
- •Any clinically significant, as determined by the investigator, abnormal laboratory evaluations, including HIVAb, HBVsAg, HBVcAb, HCVAb and liver function taken at Screening. The negative HIVAb status will be confirmed at Screening, and all HIV results will be maintained confidentially by the study site.
- •History of malignancy, including current malignancy, with the exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ within 5 years.
- •Surgery within the 4 months prior to Screening.
- •History of splenic rupture (or participant who is asplenic), pulmonary infiltrate or pneumonia, sickle cell disease, chronic neutropenia, thrombocytopenia, or vasculitis.
- •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.
- •History of biological growth factor exposure, including but not limited to pegfilgrastim, filgrastim and other G-CSFs in the context of treatment, prophylaxis, peripheral blood stem cell mobilization, or previous investigational study setting. This also includes exclusion for history of interferon, epoetin, and IVIG exposure.
- •Receipt of live vaccination, or exposure to communicable viral diseases such as chicken pox, varicella, mumps, measles, or COVID-19 within the 4 weeks prior to Screening.
- •Use of any prescription medicine (with the exception of contraceptives) within 7 days or at least 5 half-lives, whichever was longer. Use of oral or parenteral anticoagulant or antiplatelet agents and corticosteroids should be specifically queried.
Outcomes
Primary Outcomes
Maximum Serum Concentration (Cmax) of PF-06881894
Time Frame: Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose
Cmax of PF-06881894 was defined as maximum serum concentration of PF-06881894. Observed directly from data.
Area Under the Serum Drug Concentration-time Profile From Time 0 to the Last Quantifiable Concentration (AUClast) of PF-06881894
Time Frame: Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose
AUClast of PF-06881894 was defined as area under the serum drug concentration-time profile from time 0 to the last quantifiable concentration. Linear/Log trapezoidal method was used.
Area Under the Serum Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06881894
Time Frame: Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose
AUCinf of PF-06881894 was defined as area under the serum concentration-time profile from time 0 extrapolated to infinite time.
Secondary Outcomes
- Terminal Serum Elimination Half-life (t½) of PF-06881894(Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose)
- Time for Cmax (Tmax) of PF-06881894(Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose)
- Number of Participants With Treatment Emergent Adverse Events(From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).)