Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single oral doses of PF-06273340. The effect of food on the Pharmacokinetic of PF-06273340 may also be investigated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Experimental intervention: PF-06273340 or placebo | Experimental | Subjects in Cohort 1 will receive single ascending doses of PF-06273340 or placebo to investigate the safety/tolerability and PK of PF-06273340. The effect of food on PK may also be investigated. |
|
| Cohort 2: Experimental intervention: PF-06273340 or placebo | Experimental | Subjects in Cohort 2 will receive single ascending doses of PF-06273340 or placebo to investigate the safety/tolerability and PK of PF-06273340. The effect of food on PK may also be investigated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06273340 or Placebo | Drug | PF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose | |
| Time of maximum concentration (Tmax) | 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose | |
| Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast) | 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose | |
| Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf) | 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose | |
| Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24) | 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose | |
| Apparent Clearance (CL/F) | 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose | |
| Apparent Volume of Distribution (Vz/F) | 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose | |
| t1/2 = Terminal Elimination half life | 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose | |
| Urine: Ae24 (amount excreted in urine), Ae24% (%dose excreted in urine to time 24 h) and CLr (Renal Clearance) for selected doses | up to 24 h |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | B-1070 | Belgium |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PF-06273340 or Placebo | Drug | PF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution. |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000620071 | PF-06273340 |
Not provided
Not provided
Not provided