You are here

Our science / Clinical Trials / Find a Trial / NCT01992614

A Single Dose Study Of PF-06678552 In Healthy Subjects

Back to Search Print Save as PDF Bookmark Trial

NCT01992614

Last updated on November 12, 2019
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brussels, , B-1070 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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 and/or female subjects of non childbearing potential.

- Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight >50 kg

- Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL

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)

NCT01992614
Pfizer
Completed
A Single Dose Study Of PF-06678552 In Healthy Subjects

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Advanced Search

Based on your search, you may also be interested in

Healthy
Study of Single Ascending Doses of PF-07081532 in Healthy Adult Participants
NCT04148209
All Genders
18+
Years
Brussels,
Hepatic Impairment, Healthy Volunteers
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
NCT04091061
All Genders
18+
Years
Multiple Sites
Healthy Volunteers
A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants
NCT04092595
All Genders
18+
Years
Brussels, Be-bru
Healthy
A Drug Drug Interaction Study Between PF-06826647 And Oral Contraceptive Steroids In Healthy Female Participants
NCT04134715
Females
Descriptive Information
Brief Title  ICMJE A Single Dose Study Of PF-06678552 In Healthy Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Fed And Fasted Administration Of Single Escalating Oral Doses In Healthy Subjects
Brief SummaryPF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.
Detailed DescriptionNot 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 Healthy
Intervention  ICMJE Drug: PF-06678552 or Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
Study Arms  ICMJE
  • Experimental: Cohort 1
    Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
    Intervention: Drug: PF-06678552 or Placebo
  • Experimental: Cohort 2
    Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
    Intervention: Drug: PF-06678552 or Placebo
  • Experimental: Cohort 3
    Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
    Intervention: Drug: PF-06678552 or Placebo
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: March 27, 2014)		24
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2013)		36
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion DateMarch 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential.
  • Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight >50 kg
  • Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL

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)
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 NCT01992614
Other Study ID Numbers  ICMJE B7611001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 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]

Call Now