Skip to main content
OpenTrials
Completed

NCT Number: NCT03534648

Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects

Drug drug interaction study between PF-05221304 and PF-06865571

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

-

Treatment and study plan

PF-06865571 administered Day 7-14

Drug

PF-06865571 administered Q12hr on Days 7-14

PF-06865571 administered Day 1-14

Drug

PF-06865571 administered Q12hr on Day 7-14

PF-05221304 administered Day 1-14

Drug

PF-05221304 administered Q12hr on Days 1-14

PF-05221304 administered Day 7-14

Drug

PF-05221304 administered Q12hr Days 7-14

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 23, 2018
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.