NCT00722306

Brief Summary

To determine the mass balance of PD 0200390

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
Last Updated

February 4, 2011

Status Verified

February 1, 2011

Enrollment Period

Same day

First QC Date

July 23, 2008

Last Update Submit

February 3, 2011

Conditions

Keywords

non-restorativesleep

Outcome Measures

Primary Outcomes (1)

  • Radioactivity parameters in plasma and whole blood - Cmax , Tmax , AUCinf, AUClast, t1/2, CL/F and V/F and Total 14C data in blood, urine and feces

    2 days

Secondary Outcomes (1)

  • % urinary recovery

    2 days

Study Arms (1)

A425

EXPERIMENTAL

A425 Treated

Drug: PD 0200390

Interventions

Extemporaneous solution of C14 Labelled PD 0200390 60 mg single dose

A425

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy

You may not qualify if:

  • unhealthy, or concomitant meds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

(1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

February 4, 2011

Record last verified: 2011-02

Locations