Phase 1
Completed N=24
Relative Drug Exposures Of Two Formulations of PF-02341066
Healthy
Source: ClinicalTrials.gov NCT00939731 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) — 2804.5; 2597.3 ng*hr/mL
Summary
The study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over, single-dose study employing administration of two PF-02341066 formulations in the fasted state to healthy adult volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
2804.5; 2597.3 | — |
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) |
2945.5; 2722.5 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
113.35; 112.11 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
6.00; 6.00 | — |
| SECONDARY Plasma Decay Half Life (t1/2) |
29.48; 29.10 | — |
| SECONDARY Apparent Oral Clearance (CL/F) |
84.9; 91.8 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) |
3566.8; 3809.3 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and/or female of non-childbearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram(ECG) and clinical laboratory tests).
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- Pregnant or nursing females; females of childbearing potential, including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory Follicle-stimulating hormone(FSH) test results at Screening.
Data sourced from ClinicalTrials.gov (NCT00939731). 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.