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
Not provided
Not provided
The purpose of this study is to investigate if PD 0332334 affects the pharmacokinetics of lithium by co-administering both drugs to healthy adults.
Additional Study Purpose Details: To investigate potential drug-drug interaction between PD 0332334 and lithium
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a | Experimental | Subjects are treated with single dose lithium first. Then after at least 7 day washout, the subjects start PD 0332334 treatment from day 1 to day 9. At day 4 of PD 0332334 treatment, single dose lithium is given to subjects. |
|
| Cohort 1b | Experimental | Subjects are treated with PD 0332334 from day 1 to 9 and a single dose of lithium is given at day 4. After at least 7 day washout, the subjects are treated with single dose of lithium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium | Drug | 300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lithium pharmacokinetic endpoints: area under curve from 0 to infinity (AUCinf), area under curve from 0 to last quantifiable concentration (AUClast), half-life (T1/2), and maximum serum concentration (Cmax). | 10 days | |
| The nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; clinical safety lab; 12-lead ECG; and vital signs will be monitored in this study. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| No Secondary Outcomes | No Secondary Outcomes |
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 |
Not provided
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
| ID | Term |
|---|---|
| D008094 | Lithium |
| C583768 | imagabalin |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PD 0332334 | Drug | 225 mg q12h PD 0332334, oral, 9 days treatment |
|
|
| Lithium | Drug | 300 mg lithium, oral, at day 4 of PD 0332334 treatment and after 7 day washout |
|
| PD 0332334 | Drug | 225 mg q12h PD 0332334, oral, 9 days treatment |
|
| D008670 |
| Metals |