Clinical trial NCT03309241: First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06882961 In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-10-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-06882961 in healthy adult subjects. This is the first clinical study of PF-06882961.


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
* Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug 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 IP (whichever is longer).
* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Seriousness and Relationship to Treatment
timeFrame: First dose of study drug up to 28 days after last dose of study drug
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: