Single Dose Study of PF-06815345 in Healthy Subjects

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NCT02654899

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Study Location
Pfizer Clinical Research Unit
Brussels, , 1070, Belgium
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia
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 males and female of non-childbearing potential;

- Age of 18-55, inclusive;

- Body Mass Index 17.5-34.9 kg/m2, inclusive;

- Body weight >50 kg;

- Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

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


- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
(including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at
time of dosing)

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Advanced Information
Descriptive Information
Brief Title  ICMJE Single Dose Study of PF-06815345 in Healthy Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06815345, As Well As Characterize The Pharmacokinetics Of Two Formulations And Effect Of Food On Pharmacokinetics Of One Formulation Of Pf?06815345 Administered To Healthy Adult Subjects
Brief Summary The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: PF-06815345
    PF-06815345 will be administered as a liquid dosage formulation
  • Other: Placebo
    Placebo
  • Drug: PF-06815345
    PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation
Study Arms  ICMJE
  • Experimental: Part 1_Cohort 1_Active;
    Single ascending dose of PF-06815345
    Intervention: Drug: PF-06815345
  • Placebo Comparator: Part 1_Cohort 1_Placebo;
    Single dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part 1_Cohort 2_Active
    Single ascending dose of PF-06815345
    Intervention: Drug: PF-06815345
  • Placebo Comparator: Part 1_Cohort 2_Placebo
    Single dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part 2
    Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345
    Intervention: Drug: PF-06815345
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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 2, 2016)		25
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2016)		36
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males and female of non-childbearing potential;
  • Age of 18-55, inclusive;
  • Body Mass Index 17.5-34.9 kg/m2, inclusive;
  • Body weight >50 kg;
  • Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

Exclusion Criteria:

- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02654899
Other Study ID Numbers  ICMJE C0281001
2015-003935-36 ( EudraCT Number )
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 CenterPfizer
PRS Account Pfizer
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP