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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03534648
• Other study ID #: C3711002
• Secondary ID: DDI2018-000694-7
• Status: Completed
• Phase: Phase 1
• Start date: April 19, 2018
• Est. completion date: August 29, 2018

Study information

• Verified date: September 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 29, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06865571 administered Day 7-14
PF-06865571 administered Q12hr on Days 7-14
• PF-06865571 administered Day 1-14
PF-06865571 administered Q12hr on Day 7-14
• PF-05221304 administered Day 1-14
PF-05221304 administered Q12hr on Days 1-14
• PF-05221304 administered Day 7-14
PF-05221304 administered Q12hr Days 7-14

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.	Day 7, 0-12 hours and Day 14 0-12 hours
Primary	Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)	Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)	Day 7, 0-12 hours and Day 14 0-12 hours
Primary	Arm 2: PF-06865571 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.	Day 7, 0-12 hours and Day 14 0-12 hours
Primary	Arm 2: PF-06865571 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)	Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)	Day 7, 0-12 hours and Day 14 0-12 hours
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	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.	Screening up to 28 days after last dose of study medication

External Links

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