Phase 1
Completed N=6
Radiolabeled [14C]PF-02341066 Study To Investigate The Absorption, Metabolism And Excretion In Healthy Male Volunteers
Healthy Volunteer
Source: ClinicalTrials.gov NCT01082380 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) — 109.400 ng/mL
Summary
The rationale for this study is to investigate the absorption, metabolism and excretion of [14C]PF 02341066 and characterize plasma, fecal and urinary radioactivity, and identify any metabolites, if possible, of [14C]PF 02341066 in humans.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
109.400 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
2.99 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Plasma Concentration (AUClast) |
2686.0 | — |
| PRIMARY Area Under the Plasma Concentration Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |
2777.0 | — |
| PRIMARY Plasma Decay Half Life (t1/2) |
93.970 | — |
| PRIMARY Apparent Oral Clearance (CL/F) of Plasma PF-02341066 |
90.140 | — |
| PRIMARY Apparent Volume of Distribution (V/F) in Plasma |
12110.0 | — |
| PRIMARY Renal Clearance (CLr) of PF-02341066 |
2.11 | — |
| PRIMARY Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to Infinite Time (Ae) |
5.847 | — |
| PRIMARY Total Amount of Unchanged Drug Excreted in the Urine Expressed as Percent of Dose From Time Zero to Infinite Time [Ae(%)] |
2.339 | — |
| PRIMARY Maximum Observed Concentration in Plasma Radioactivity (Cmax) |
435.600 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Radioactivity Concentration (Tmax) |
5.00 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Plasma Radioactivity Concentration (AUClast) |
22830.0 | — |
| PRIMARY Area Under the Plasma Radioactivity Concentration Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |
— | — |
| PRIMARY Decay Half Life (t1/2) of Radioactivity in Plasma |
— | — |
| PRIMARY Apparent Oral Clearance (CL/F) of Plasma Radioactivity |
— | — |
| PRIMARY Apparent Volume of Distribution (V/F) in Plasma Radioactivity |
— | — |
| PRIMARY Maximum Observed Concentration of Radioactivity in Whole Blood (Cmax) |
312.300 | — |
| PRIMARY Time to Reach Maximum Observed Concentration (Tmax) of Radioactivity in Whole Blood |
4.00 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Radioactivity in Whole Blood |
7032.0 | — |
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Radioactivity in Whole Blood |
— | — |
| PRIMARY Decay Half-life (t1/2) of Radioactivity in Whole Blood |
— | — |
| PRIMARY Apparent Oral Clearance of Radioactivity From Whole Blood (CL/F) |
— | — |
| PRIMARY Apparent Volume of Distribution of Radioactivity in Whole Blood (V/F) |
— | — |
| PRIMARY Total [14C] Data in Urine |
56200000 | — |
| PRIMARY Total [14C] Data in Feces |
160000000 | — |
| PRIMARY Overall Cumulative Percent Recovery of Radioactivity |
22.20; 63.10; 85.20 | — |
| PRIMARY Identification and Profiling of Metabolites of [14C]PF-02341066 in Plasma |
33.1; 10.2 | — |
| PRIMARY Identification and Profiling of Metabolites of [14C]PF-02341066 in Feces |
53.5; NA | — |
| PRIMARY Identification and Profiling of Metabolites of [14C]PF-02341066 in Urine |
2.4; 4.5 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male 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 ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
Data sourced from ClinicalTrials.gov (NCT01082380). 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.