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Study to Determine the Absorption, Metabolism, and Excretion of [14C]LX4211 in Healthy Male Subjects (AME)

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ClinicalTrials.gov Identifier: NCT01818232
Recruitment Status : Completed
First Posted : March 26, 2013
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: [14C]-LX4211 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 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
Study Start Date : March 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: [14C]-LX4211
400 mg LX4211 administered orally
Drug: [14C]-LX4211



Primary Outcome Measures :
  1. Area Under Curve (AUC) [ Time Frame: Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose ]

Secondary Outcome Measures :
  1. Number of subjects experiencing an adverse event [ Time Frame: Day 1 through discharge ]
  2. Urinary recovery of radioactivity [ Time Frame: predose through 24 hours ]
  3. Fecal recovery of radioactivity [ Time Frame: predose through 24 hours ]
  4. Whole blood and plasma concentration of total radioactivity [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults ≥18 to ≤55 years of age
  • 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
  • Body mass index (BMI) ≥18 and ≤35 kg/sq m
  • Historically able to produce a minimum of 1 bowel movement per day
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Female
  • Receipt of any investigational drug within 30 days prior to Dosing, or investigational protein or antibody-based therapeutic agents within 3 months prior to Screening
  • Prior exposure to LX4211
  • Use any tobacco product within 2 months prior to Screening and while participating in the study (Day -1 through Discharge)
  • History of bariatric surgery or any other GI surgery that may induce malabsorption
  • History of any major surgery within 6 months prior to Screening
  • History of renal or hepatic disease, or significantly abnormal kidney or liver function tests at Screening
  • History of any clinically relevant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, hematological, or GI abnormality
  • History of any active infection within 14 days prior to Dosing
  • History of alcohol or substance abuse within 2 years prior to Dosing
  • History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Donation or loss of >400 mL of blood or blood product within 3 months of Dosing
  • Positive urine glucose at Screening
  • Positive urine screen for drugs of abuse at Screening or Day -1
  • Positive breath test for alcohol at Screening or Day -1
  • Participation in >1 other radiolabeled investigational study drug trial within 12 months prior to Day -1
  • Exposure to significant radiation within 12 months prior to Day -1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818232


Locations
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United States, Wisconsin
Lexicon Investigational Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Ikenna Ogbaa, M.D. Lexicon Pharmaceuticals, Inc.

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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01818232     History of Changes
Other Study ID Numbers: LX4211.1-108-NRM
LX4211.108
First Posted: March 26, 2013    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs