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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06372865 or Placebo or Lorazepam; Drug: PF-06372865 or Placebo

• Registration Number: NCT01951144
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-26
• Study Start: 2013-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-15
• Last Update Posted: 2014-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 4 (optional cohort):	PF-06372865 or Placebo or Lorazepam	Two single doses of PF-06372865 or placebo or lorazepam to further investigate the pharmacodynamics of PF-06372865.
Cohort 1:	PF-06372865 or Placebo	Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.
Cohort 3:	PF-06372865 or Placebo	Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.
Cohort 2:	PF-06372865 or Placebo	Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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
Change in Body Sway	0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Smooth Pursuit	0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Bond and Lader VAS	0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Adaptive Tracking	0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Visual Verbal Learning Test	1 and 6 hours post dose
Change in Pharmaco-EEG	0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇳🇱 Leiden, CL, Netherlands