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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionHealthy
InterventionDrug: PF-06372865 or Placebo
Drug: PF-06372865 or Placebo
Drug: PF-06372865 or Placebo
Drug: PF-06372865 or Placebo or Lorazepam
PhasePhase 1
SponsorPfizer
Responsible PartyPfizer
ClinicalTrials.gov IdentifierNCT01951144
First ReceivedSeptember 13, 2013
Last UpdatedApril 24, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateSeptember 13, 2013
Last Updated DateApril 24, 2014
Start DateOctober 2013
Estimated Primary Completion DateJuly 2014
Current Primary Outcome Measures
  • Maximum Observed Plasma Concentration (Cmax) [Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose] [Designated as safety issue: No]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose] [Designated as safety issue: No]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose] [Designated as safety issue: No]
  • Apparent Oral Clearance (CL/F) [Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose] [Designated as safety issue: No]
  • Apparent Volume of Distribution (Vz/F) [Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose] [Designated as safety issue: No]
  • Plasma Decay Half-Life (t1/2) [Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose] [Designated as safety issue: No]
  • Area Under the Curve From Time Zero to 24 hours [Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose] [Designated as safety issue: No]
  • Change in Saccadic Eye Movements (saccadic reaction time, saccadic peak velocity and saccadic inaccuracy) [Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose] [Designated as safety issue: No]
  • Change in Body Sway [Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose] [Designated as safety issue: No]
  • Change in Smooth Pursuit [Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose] [Designated as safety issue: No]
  • Change in Bond and Lader VAS [Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose] [Designated as safety issue: No]
  • Change in Adaptive Tracking [Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose] [Designated as safety issue: No]
  • Change in Visual Verbal Learning Test [Time Frame: 1 and 6 hours post dose] [Designated as safety issue: No]
  • Change in Pharmaco-EEG [Time Frame: 0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleA First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865
Official TitleA 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
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
ConditionHealthy
InterventionDrug: 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.
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.
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.
Drug: PF-06372865 or Placebo or Lorazepam
Lorazepam 2 mg dose, PF-06372865 and placebo administered as tablet formulation
Study Arm (s)
  • Experimental: Cohort 1:
    Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.
  • Experimental: Cohort 2:
    Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.
  • Experimental: Cohort 3:
    Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.
  • Experimental: Cohort 4 (optional cohort):
    Two single doses of PF-06372865 or placebo or lorazepam to further investigate the pharmacodynamics of PF-06372865.

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment42
Estimated Completion DateJuly 2014
Estimated Primary Completion DateJuly 2014
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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsContact: Pfizer CT.gov Call Center
1-800-718-1021
Location CountriesNetherlands

Administrative Information[ + expand ][ + ]

NCT Number NCT01951144
Other Study ID NumbersB7431001
Has Data Monitoring CommitteeNo
Information Provided ByPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators Study Director: Pfizer CT.gov Call Center Pfizer
Verification DateApril 2014

Locations[ + expand ][ + ]

Pfizer Investigational Site
Leiden, CL, Netherlands, 2333
Recruiting