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

Last updated on June 21, 2018

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT03534648
Pfizer
Recruiting
Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects

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Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects
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
Drug drug interaction study between PF-05221304 and PF-06865571
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
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
Same as current
July 13, 2018
June 13, 2018   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Belgium
 
 
NCT03534648
C3711002
DDI ( Other Identifier: Alias Study Number )
2018-000694-70 ( EudraCT Number )
No
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
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/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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