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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01818232

Run by

Lexicon Pharmaceuticals

People needed

8

Starts

2013-03-01

Expected to finish

2013-05-01

Last updated by the study team

2013-06-18

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lexicon Investigational Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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