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Multiple Ascending Dose and DDI Study

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
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)

NCT03031119
Pfizer
Completed
Multiple Ascending Dose and DDI Study

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Multiple Ascending Dose and DDI Study
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)
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
July 2017
July 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT03031119
C1061002
2016-004649-10 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

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

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