Healthy
Conditions
Brief summary
Drug drug interaction study between PF-05221304 and PF-06865571
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
Interventions
DRUGPF-06865571 administered Day 7-14
PF-06865571 administered Q12hr on Days 7-14
DRUGPF-06865571 administered Day 1-14
PF-06865571 administered Q12hr on Day 7-14
DRUGPF-05221304 administered Day 1-14
PF-05221304 administered Q12hr on Days 1-14
DRUGPF-05221304 administered Day 7-14
PF-05221304 administered Q12hr Days 7-14
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | 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. |
| Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) | Day 7, 0-12 hours and Day 14 0-12 hours | Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) |
| Arm 2: PF-06865571 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | 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. |
| Arm 2: PF-06865571 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) | Day 7, 0-12 hours and Day 14 0-12 hours | Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Belgium
Outcome results
None listed