A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects

A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00820794

Enrollment

Registered

2009-01-12

Start date

2009-05-31

Completion date

2009-06-30

Last updated

2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disease

Keywords

Drug-drug interaction, lithium, PD 0332334, pharmacokinetics

Brief summary

The purpose of this study is to investigate if PD 0332334 affects the pharmacokinetics of lithium by co-administering both drugs to healthy adults.

Detailed description

Additional Study Purpose Details: To investigate potential drug-drug interaction between PD 0332334 and lithium

Interventions

DRUGLithium

300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment

DRUGPD 0332334

225 mg q12h PD 0332334, oral, 9 days treatment

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males and/or females * Age from 21 to 55 (inclusive) * BMI ranges from 18 to 30 kg/m2

Exclusion criteria

* Previous participation in a PD 332334 study * Pregnant or nursing females * Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)

Design outcomes

Primary

Measure	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

Secondary

Measure	Time frame
No Secondary Outcomes	No Secondary Outcomes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026