Completed
AMEA Phase 1, Open-label, Nonrandomized, Single Dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-LX4211, Following Oral Administration, in Healthy Male Subjects
What is being tested
[14C]-LX4211
Drug
Who is being recruted
From 18 to 55 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: March 2013
Summary
Principal SponsorLexicon Pharmaceuticals
Last updated: June 18, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.This phase 1 study is to evaluate the pharmacokinetics (PK), metabolism, routes and extent of elimination of a single oral dose of 400 mg [14C]LX4211 to healthy male subjects
Principal SponsorLexicon Pharmaceuticals
Last updated: June 18, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
Adults >= 18 to <= 55 years of age
Body mass index (BMI) >= 18 and <= 35 kg/sq m
Historically able to produce a minimum of 1 bowel movement per day
Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm
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17 exclusion criteria prevent from participating
Donation or loss of > 400 mL of blood or blood product within 3 months of Dosing
Exposure to significant radiation within 12 months prior to Day -1
Female
History of alcohol or substance abuse within 2 years prior to Dosing
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimental400 mg LX4211 administered orally
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center