Healthy
Conditions
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
Interventions
DRUG[14C]-LX4211
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under Curve (AUC) | Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects experiencing an adverse event | Day 1 through discharge |
| Urinary recovery of radioactivity | predose through 24 hours |
| Fecal recovery of radioactivity | predose through 24 hours |
| Whole blood and plasma concentration of total radioactivity | predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose |
Countries
United States
Outcome results
None listed