Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion of Esreboxetine (ADME)
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Purpose
The purpose of the study is to learn more about how esreboxetine is handled by the body i.e. the absorption, metabolism and excretion of esreboxetine.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: [14C]-esreboxetine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open Label, Single Oral Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Esreboxetine. |
- Cumulative excretion of radioactivity in urine and and faeces as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and faeces for the assessment of parent drug and metabolites of esreboxetine where possible [ Time Frame: Approx 10 days ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters of esreboxetine and identification and abundance of metabolites in plasma, urine and faeces if possible [ Time Frame: Approx 10 days ] [ Designated as safety issue: No ]
- Clinical safety data [ Time Frame: Approx 10 days ] [ Designated as safety issue: Yes ]
- Pharmacokinetic parameters of plasma esreboxetine metabolites if possible [ Time Frame: Approx 10 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 4 |
| 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 oral dose of [14C]-esreboxetine |
Drug: [14C]-esreboxetine
Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi [14C]-esreboxetine
|
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy male subjects aged 45 to 65 years Body mass index (BMI=weight/height2) 18 to 30 kg/m2
Exclusion Criteria:
Any clinically relevant abnormality identified on the screening medical assessment Any condition possibly affecting drug absorption Subjects with exposure to significant radiation (eg serial Xray or CT scans, barium meal etc)or who have participated in a radiolabelled study in the past 12 months, or who have occupational exposure to radioactivity History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5ounces (150ml) of wine or 12 ounces (360ml) of beer or 1.5 ounces (45ml) of hard liquor) within 6 months of screening 12-lead ECG demonstrating QTc>450mses at screening Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00800956 History of Changes |
| Other Study ID Numbers: | A6061018 |
| Study First Received: | December 2, 2008 |
| Last Updated: | April 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Radiolabel ADME study Healthy volunteers |
ClinicalTrials.gov processed this record on May 19, 2013