Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body

This study has been terminated.
(Please see Detailed Description for termination reason.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00800280
First received: December 1, 2008
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.


Condition Intervention Phase
Generalized Anxiety Disorder
Drug: PD 0332334
Drug: cimetidine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of Steady-State Cimetidine On The Pharmacokinetics Of A Single Dose Of PD 0332334 In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf) [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]
  • PD 0332334 AUC from 0 to last quantifiable concentration (AUClast) [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]
  • Half-life (t1/2) of PD 0332334 [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of PD 0332334 [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the incidence, duration and severity of adverse events [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
  • Evaluate the discontinuation due to adverse events [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
  • Clinical safety labs [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single dose PD 0332334 Drug: PD 0332334
Single 300 mg dose of PD 0332334 immediate release capsules administered orally
Other Name: imagabalin
Experimental: Single dose PD 0332334 with steady-state cimetidine Drug: PD 0332334
Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.
Drug: cimetidine
600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.

Detailed Description:

Detailed Description:

Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334.

On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy
  • male or female adults

Exclusion Criteria:

  • Current or history of clinically significant medical illness
  • Smokers
  • Illicit drug use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800280

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00800280     History of Changes
Other Study ID Numbers: A5361030
Study First Received: December 1, 2008
Last Updated: February 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
cimetidine, PD 0332334, organic cation transporter, OCT2, pharmacokinetics

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014