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A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: PF-06372865 or Placebo (Drug); PF-06372865 or Placebo (Drug); PF-06372865 or Placebo (Drug); PF-06372865 or Placebo or Lorazepam (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome:

Maximum Observed Plasma Concentration (Cmax)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Area Under the Curve From Time Zero to Extrapolated Infinite Time

Apparent Oral Clearance (CL/F)

Apparent Volume of Distribution (Vz/F)

Plasma Decay Half-Life (t1/2)

Area Under the Curve From Time Zero to 24 hours

Change in Saccadic Eye Movements (saccadic reaction time, saccadic peak velocity and saccadic inaccuracy)

Change in Body Sway

Change in Smooth Pursuit

Change in Bond and Lader VAS

Change in Adaptive Tracking

Change in Visual Verbal Learning Test

Change in Pharmaco-EEG

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Leiden, CL 2333, Netherlands
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: October 2013
Last updated: August 15, 2014

Page last updated: August 23, 2015

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