A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: 8.0 mg PF-06649751
Drug: 0.5 mg PF-06649751
Drug: 1.5 mg PF-06649751 21 Days
Drug: 0.15 mg PF-06649751
Drug: 5.0 mg PF-06649751
Drug: 1.5 mg PF-06649751 in healthy Japanese subjects
Drug: 1.5 mg PF-06649751
Drug: 3.0 mg PF-06649751
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days (Cohorts 6 - 8). Cohort 9 will dose Japanese healthy volunteers in a manner identical to Cohort 4 and is intended to bridge the safety/tolerability and PK data from the Western and Japanese populations.
Enrollment
77 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Healthy males and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Cohort 9 only: Japanese subjects must have four biologic Japanese grandparents who were born in Japan.
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).
- Other severe acute or chronic medical or psychiatric condition 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 subject inappropriate for entry into this study.
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
77 participants in 9 patient groups
Cohort 1
Experimental group
Description:
Dosing in healthy Western subjects.
Treatment:
Drug: 0.15 mg PF-06649751
Cohort 2
Experimental group
Description:
Dosing in healthy Western subjects.
Treatment:
Drug: 0.5 mg PF-06649751
Drug: 0.5 mg PF-06649751
Cohort 3
Experimental group
Description:
Dosing in healthy Western subjects.
Treatment:
Drug: 0.5 mg PF-06649751
Drug: 0.5 mg PF-06649751
Cohort 4
Experimental group
Description:
Dosing in healthy Western subjects.
Treatment:
Drug: 1.5 mg PF-06649751
Cohort 5
Experimental group
Description:
Dosing in healthy Western subjects.
Treatment:
Drug: 1.5 mg PF-06649751 21 Days
Cohort 6
Experimental group
Description:
Dosing in healthy Western subjects.
Treatment:
Drug: 3.0 mg PF-06649751
Cohort 7
Experimental group
Description:
Dosing in healthy Western subjects.
Treatment:
Drug: 5.0 mg PF-06649751
Optional Cohort 8
Experimental group
Description:
Dosing in healthy Western subjects. Cohort may not be conducted.
Treatment:
Drug: 8.0 mg PF-06649751
Cohort 9
Experimental group
Description:
Dosing in healthy Japanese subjects.
Treatment:
Drug: 1.5 mg PF-06649751 in healthy Japanese subjects
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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