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Trial record 1 of 1 for:    NCT03534648
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Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT03534648
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE May 23, 2018
Last Update Posted Date September 18, 2018
Actual Study Start Date  ICMJE April 19, 2018
Actual Primary Completion Date July 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
  • Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: Day 7, 0-12 hours and Day 14 0-12 hours ]
    Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
  • Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) [ Time Frame: Day 7, 0-12 hours and Day 14 0-12 hours ]
    Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
  • Arm 2: PF-06865571 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: Day 7, 0-12 hours and Day 14 0-12 hours ]
    Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
  • Arm 2: PF-06865571 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) [ Time Frame: Day 7, 0-12 hours and Day 14 0-12 hours ]
    Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03534648 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Screening up to 28 days after last dose of study medication ]
Treatment-emergent AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects
Official Title  ICMJE A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects
Brief Summary Drug drug interaction study between PF-05221304 and PF-06865571
Detailed Description A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06865571 administered Day 7-14
    PF-06865571 administered Q12hr on Days 7-14
  • Drug: PF-06865571 administered Day 1-14
    PF-06865571 administered Q12hr on Day 7-14
  • Drug: PF-05221304 administered Day 1-14
    PF-05221304 administered Q12hr on Days 1-14
  • Drug: PF-05221304 administered Day 7-14
    PF-05221304 administered Q12hr Days 7-14
Study Arms  ICMJE
  • Experimental: Effect of PF-05221304 on PF-06865571 PK
    Interventions:
    • Drug: PF-06865571 administered Day 7-14
    • Drug: PF-05221304 administered Day 1-14
  • Experimental: Effect of PF-06865571 on PF-05221304 PK
    Interventions:
    • Drug: PF-06865571 administered Day 1-14
    • Drug: PF-05221304 administered Day 7-14
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: May 11, 2018)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 29, 2018
Actual Primary Completion Date July 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Healthy female subjects of nonchildbearing potential and/or male subjects.
  2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
  2. Any condition possibly affecting drug absorption.
  3. A positive urine drug test.
  4. Screening supine BP 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  5. Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec.

    -

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 NCT03534648
Other Study ID Numbers  ICMJE C3711002
DDI ( Other Identifier: Alias Study Number )
2018-000694-70 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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/data_requests
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 September 2018

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