A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers

A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00722306

Enrollment

Registered

2008-07-25

Start date

2008-05-31

Completion date

2008-05-31

Last updated

2011-02-04

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

Conditions

Insomnia

Keywords

non-restorative, sleep

Brief summary

To determine the mass balance of PD 0200390

Interventions

DRUGPD 0200390

Extemporaneous solution of C14 Labelled PD 0200390 60 mg single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy

Exclusion criteria

* unhealthy, or concomitant meds

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
% urinary recovery	2 days

Countries

United States

Outcome results

None listed

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