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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment
225 mg q12h PD 0332334, oral, 9 days treatment
300 mg lithium, oral, at day 4 of PD 0332334 treatment and after 7 day washout
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).
Time frame: 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.
Time frame: 10 days
No Secondary Outcomes
Time frame: No Secondary Outcomes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
225 mg q12h PD 0332334, oral, 9 days treatment