Clinical trial NCT01951144: A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865
Official title: A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06372865 in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Single Dose
Pharmacokinetics
Safety
Toleration
Pharmacodynamics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single oral doses of PF-06372865. The pharmacodynamic activity of PF-06372865 will also be assessed. The effect of food on PK and the PK of PF-06372865 administered as a tablet formulation may also be investigated. Pharmacodynamic interaction between PF-06372865 and lorazepam will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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 time of dosing).
* Any condition possibly affecting drug absorption (e.g., gastrectomy).
* A positive urine drug screen.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
measure: Apparent Oral Clearance (CL/F)
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
measure: Area Under the Curve From Time Zero to 24 hours
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
measure: Change in Saccadic Eye Movements (saccadic reaction time, saccadic peak velocity and saccadic inaccuracy)
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
measure: Change in Body Sway
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
measure: Change in Smooth Pursuit
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
measure: Change in Bond and Lader VAS
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
measure: Change in Adaptive Tracking
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
measure: Change in Visual Verbal Learning Test
timeFrame: 1 and 6 hours post dose
measure: Change in Pharmaco-EEG
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Pfizer Investigational Site
state: CL
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: