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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

Last updated on December 12, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Leiden, CL, 2333 Netherlands
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01951144
Pfizer
Completed
A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865

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Descriptive Information
Brief Title  ICMJE A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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 Dose 1, PF-06372865 Dose 2, PF-06372865 Dose 1 and Dose 2 in combination with lorazepam, placebo administered as tablet formulation
Study Arms  ICMJE
  • Experimental: Cohort 1:
    Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.
    Intervention: Drug: PF-06372865 or Placebo
  • Experimental: Cohort 2:
    Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.
    Intervention: Drug: PF-06372865 or Placebo
  • Experimental: Cohort 3:
    Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.
    Intervention: Drug: PF-06372865 or Placebo
  • Experimental: Cohort 4 (optional cohort):
    Two single doses of PF-06372865 or placebo or lorazepam to further investigate the pharmacodynamics of PF-06372865.
    Intervention: Drug: PF-06372865 or Placebo or Lorazepam
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2014)
45
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2013)
32
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01951144
Other Study ID Numbers  ICMJE B7431001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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