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

NCT01951144 | Completed Phase 1

• 1 other identifier: B7431001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Phase 1; Single Dose; Pharmacokinetics; Safety; Toleration; Pharmacodynamics

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

Study Arms (4)

Cohort 1:

EXPERIMENTAL

Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.

Drug: PF-06372865 or Placebo

Cohort 2:

EXPERIMENTAL

Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.

Drug: PF-06372865 or Placebo

Cohort 3:

EXPERIMENTAL

Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.

Drug: PF-06372865 or Placebo

Cohort 4 (optional cohort):

EXPERIMENTAL

Two single doses of PF-06372865 or placebo or lorazepam to further investigate the pharmacodynamics of PF-06372865.

Drug: PF-06372865 or Placebo or Lorazepam

Interventions

PF-06372865 or Placebo DRUG

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.

Cohort 1:

PF-06372865 or Placebo or Lorazepam DRUG

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

Cohort 4 (optional cohort):

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Leiden, CL, 2333, Netherlands

Location

Related Links

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

MeSH Terms

Interventions

PF-06372865; Lorazepam

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 26, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

NL (1)