Healthy Volunteers
Conditions
Keywords
pharmacokinetics, JAK inhibitor, PF-06651600
Brief summary
The study will be conducted as a Phase 1, open-label, single dose, randomized, 4-period, cross over design in a single cohort of approximately 12 healthy male or female participants at a single center. Participants will be randomized into 1 of 4 sequences of treatment.
Interventions
DRUGPF-06651600
PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and 12 lead ECG. * Participants with body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600 | Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4. |
| Maximum plasma PF-06651600 concentration (C max) | Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4. |
Secondary
| Measure | Time frame |
|---|---|
| Single dose plasma decay half-life (t 1/2) of PF-06651600 | Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4. |
| Single dose Apparent Oral Clearance (CL/F) of PF-06651600 | Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4. |
| Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600 | Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4. |
| Frequency of abnormal safety laboratory tests | Baseline up to day 9 |
| Frequency of Adverse Events | Baseline up to Day 35 |
| Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600 | Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4. |
| Single dose Area under the Curve from Time Zero to Last quantifiable concentration [AUC last) of PF-06651600 | Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4. |
Countries
Belgium
Outcome results
None listed