Multiple Ascending Dose and DDI Study

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NCT03031119

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070, Belgium
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Contact
1-800-718-1021
[email protected]
Related Links

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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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
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 females (nonchildbearing potential)

- 18 to 55 years old

- Body Mass Index 17.5 to 30.5

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


- Known hereditary fructose intolerance or fructose malabsorption disorder (Part A)


- Statin intolerance (Part B)


- Unable to consume high fructose syrup-containing beverage with each meal while in the
unit (Part A)

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE Multiple Ascending Dose and DDI Study
Official Title  ICMJE A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability, And Pharmacokinetics Of Multiple Oral Doses Of Pf-06835919 In Healthy Adult Subjects (Part A); And An Open-label Study To Assess Multiple Oral Doses Of Pf-06835919 On Atorvastatin Pharmacokinetics (Part B)
Brief Summary Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for 14 days in a multiple ascending dose design. Part B will assess the effect of PF-06835919 co-administration at low and high doses on the PK of atorvastatin in a single cohort.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Placebo
    Tablets administered once or twice daily, with food, in Part A.
  • Drug: PF-06835919
    Tablets administered once or twice daily, with food, in Part A. Tablets administered once or twice daily, with food and atorvastatin in Part B.
  • Drug: atorvastatin
    In Part B, tablets administered once or twice daily, with food, with and without PF-06835919.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Tablets administered once or twice daily, with food, in Part A for 14 days.
    Intervention: Drug: Placebo
  • Experimental: PF-06835919
    Tablets administered once or twice daily, with food, in Part A for 14 days. Tablets administered once or twice daily, for 4 days at a low dose and for 4 days at a higher dose, with food and atorvastatin in Part B.
    Interventions:
    • Drug: PF-06835919
    • Drug: atorvastatin
  • Experimental: atorvastatin
    In Part B, tablets administered once or twice daily, with food, with and without a low dose of PF-06835919 for 4 days and a higher dose of PF-06835919 for 4 days.
    Interventions:
    • Drug: PF-06835919
    • Drug: atorvastatin
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: September 5, 2017)		62
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)		72
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and females (nonchildbearing potential)
  • 18 to 55 years old
  • Body Mass Index 17.5 to 30.5

Exclusion Criteria:

  • Known hereditary fructose intolerance or fructose malabsorption disorder (Part A)
  • Statin intolerance (Part B)
  • Unable to consume high fructose syrup-containing beverage with each meal while in the unit (Part A)
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 NCT03031119
Other Study ID Numbers  ICMJE C1061002
2016-004649-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/d…
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 2017

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