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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951144
• Other study ID #: B7431001
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2013
• Last updated: August 15, 2014
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06372865 or Placebo
PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.
• PF-06372865 or Placebo
PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.
• PF-06372865 or Placebo
PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.
• PF-06372865 or Placebo or Lorazepam
Lorazepam 2 mg dose, PF-06372865 Dose 1, PF-06372865 Dose 2, PF-06372865 Dose 1 and Dose 2 in combination with lorazepam, placebo administered as tablet formulation

Locations

Country	Name	City	State
Netherlands	Pfizer Investigational Site	Leiden	CL

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose	No
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose	No
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time		0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose	No
Primary	Apparent Oral Clearance (CL/F)		0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose	No
Primary	Apparent Volume of Distribution (Vz/F)		0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose	No
Primary	Plasma Decay Half-Life (t1/2)		0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose	No
Primary	Area Under the Curve From Time Zero to 24 hours		0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose	No
Primary	Change in Saccadic Eye Movements (saccadic reaction time, saccadic peak velocity and saccadic inaccuracy)		0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose	No
Primary	Change in Body Sway		0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose	No
Primary	Change in Smooth Pursuit		0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose	No
Primary	Change in Bond and Lader VAS		0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose	No
Primary	Change in Adaptive Tracking		0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose	No
Primary	Change in Visual Verbal Learning Test		1 and 6 hours post dose	No
Primary	Change in Pharmaco-EEG		0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose	No

External Links

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