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

Pfizer

Status and phase: Withdrawn; Phase 1

Conditions: Generalized Anxiety Disease

Treatments: Drug: PD 0332334; Drug: Lithium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00820794

A5361034

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

0 participants in 2 patient groups

Cohort 1a

Experimental group

Description:

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.

Treatment:

Drug: Lithium

Drug: PD 0332334

Drug: Lithium

Drug: PD 0332334

Cohort 1b

Experimental group

Description:

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.

Treatment:

Drug: Lithium

Drug: PD 0332334

Drug: Lithium

Drug: PD 0332334