A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: PF-06648671

Study type: Interventional

Funder types: Industry

Identifiers

NCT02316756

2014-004394-17 (EudraCT Number)

B7991001

Details and patient eligibility

About

This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending doses of PF-06648671 in healthy subjects.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects of non childbearing potential
• BMI of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
• Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study.

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drg allergies, but excluding untreated asymptomatic, seasonal allergies at the time of dosing);
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer)
• 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 judgement of the investigator, would make the subject inappropriate for entry into this study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 3 patient groups

Single Ascending Doses Cohort 1

Experimental group

Description:

subjects receive 3 active doses and one placebo

Treatment:

Drug: PF-06648671

Drug: Placebo

Single Ascending Doses Cohort 2

Experimental group

Description:

subjects receive 3 doses and one placebo

Treatment:

Drug: PF-06648671

Drug: Placebo

Cohort 3

Experimental group

Description:

optional cohort

Treatment:

Drug: PF-06648671

Drug: Placebo