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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

Brief Summary:
Drug drug interaction study between PF-05221304 and PF-06865571

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-06865571 administered Day 7-14 Drug: PF-06865571 administered Day 1-14 Drug: PF-05221304 administered Day 1-14 Drug: PF-05221304 administered Day 7-14 Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : April 19, 2018
Actual Primary Completion Date : July 16, 2018
Actual Study Completion Date : August 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Effect of PF-05221304 on PF-06865571 PK Drug: PF-06865571 administered Day 7-14
PF-06865571 administered Q12hr on Days 7-14

Drug: PF-05221304 administered Day 1-14
PF-05221304 administered Q12hr on Days 1-14

Experimental: Effect of PF-06865571 on PF-05221304 PK Drug: PF-06865571 administered Day 1-14
PF-06865571 administered Q12hr on Day 7-14

Drug: PF-05221304 administered Day 7-14
PF-05221304 administered Q12hr Days 7-14




Primary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.

  4. 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)


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534648


Locations
Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03534648     History of Changes
Other Study ID Numbers: C3711002
DDI ( Other Identifier: Alias Study Number )
2018-000694-70 ( EudraCT Number )
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
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

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