Status:
COMPLETED
Study to Determine the Absorption, Metabolism, and Excretion of [14C]LX4211 in Healthy Male Subjects
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01818232
Start Date
March 1 2013
End Date
May 1 2013
Last Update
June 18 2013
Active Locations (1)
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1
Lexicon Investigational Site
Madison, Wisconsin, United States, 53704