Phase 1
Completed N=12
A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT02804399 ↗
Enrolled (actual)
12
Serious AEs
13.9%
Results posted
Jan 2019
Primary outcomePrimary: Plasma AUCinf for PF-06463922 Given Alone and With Rifampin — 8766; 1299 nanogram (ng)*hr/ millilitre (mL)
Summary
The purpose of this study is to estimate the effect of rifampin on the single dose PK of PF-06463922.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma AUCinf for PF-06463922 Given Alone and With Rifampin |
8766; 1299 | — |
| PRIMARY Plasma Cmax for PF-06463922 Given Alone and With Rifampin |
621.4; 148.4 | — |
| SECONDARY Plasma AUClast for PF-06463922 Given Alone and With Rifampin |
8597; 1200 | — |
| SECONDARY Plasma Tmax for PF-06463922 Given Alone and With Rifampin |
1.50; 1.51 | — |
| SECONDARY Plasma t1/2 for PF-06463922 Given Alone and With Rifampin |
21.22; 10.16 | — |
| SECONDARY Plasma CL/F for PF-06463922 Given Alone and With Rifampin |
11.39; 76.91 | — |
| SECONDARY Plasma Vz/F for PF-06463922 Given Alone and With Rifampin |
342.6; 1095 | — |
| SECONDARY Plasma AUClast for PF-06895751 When PF-06463922 Given Alone and With Rifampin |
4105; 3169 | — |
| SECONDARY Plasma AUCinf for PF-06895751 When PF-06463922 Given Alone and With Rifampin |
4453; 3291 | — |
| SECONDARY Plasma Tmax for PF-06895751 When PF-06463922 Given Alone and With Rifampin. |
30.1; 12.0 | — |
| SECONDARY Plasma t1/2 for PF-06895751 When PF-06463922 Given Alone and With Rifampin |
29.14; 18.43 | — |
| SECONDARY Plasma Cmax for PF-06895751 When PF-06463922 Given Alone and With Rifampin |
59.02; 76.45 | — |
| SECONDARY Plasma Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for Cmax (MRCmax) of PF-06463922 and Its Metabolite: When PF-06463922 Given Alone and With Rifampin |
0.2094; 1.136 | — |
| SECONDARY Plasma Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUClast (MRAUClast) of PF-06463922 and Its Metabolite: When PF-06463922 Given Alone and With Rifampin |
1.053; 5.831 | — |
| SECONDARY Plasma Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUCinf (MRAUCinf) of PF-06463922 and Its Metabolite: When PF-06463922 Given Alone and With Rifampin |
1.166; 5.521 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy female subjects of non-childbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- Any condition possibly affecting drug absorption
- Positive urine drug screen
- History of HIV, Hep B or Hep C
- History of regular alcohol consumption
- History of cardiac arrhythmia, history of AV block, history of symptomatic bradycardia, history of QTc prolongation
- History of pancreatitis or hyperlipidemia, elevated lipase
Data sourced from ClinicalTrials.gov (NCT02804399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.