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

NCT03534648 | Completed Phase 1 FDA Drug

• 3 other identifiers: C3711002DDI2018-000694-70
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Screening up to 28 days after last dose of study medication

Study Arms (2)

Effect of PF-05221304 on PF-06865571 PK

EXPERIMENTAL

Drug: PF-06865571 administered Day 7-14; Drug: PF-05221304 administered Day 1-14

Effect of PF-06865571 on PF-05221304 PK

EXPERIMENTAL

Drug: PF-06865571 administered Day 1-14; Drug: PF-05221304 administered Day 7-14

Interventions

PF-06865571 administered Day 7-14 DRUG

PF-06865571 administered Q12hr on Days 7-14

Effect of PF-05221304 on PF-06865571 PK

PF-06865571 administered Day 1-14 DRUG

PF-06865571 administered Q12hr on Day 7-14

Effect of PF-06865571 on PF-05221304 PK

PF-05221304 administered Day 1-14 DRUG

PF-05221304 administered Q12hr on Days 1-14

Effect of PF-05221304 on PF-06865571 PK

PF-05221304 administered Day 7-14 DRUG

PF-05221304 administered Q12hr Days 7-14

Effect of PF-06865571 on PF-05221304 PK

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 23, 2018
• Study Start: April 19, 2018
• Primary Completion: July 16, 2018
• Study Completion: August 29, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)