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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C]-LX4211

• Registration Number: NCT01818232
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-26
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]-LX4211	[14C]-LX4211	400 mg LX4211 administered orally

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Fecal recovery of radioactivity	predose through 24 hours
Number of subjects experiencing an adverse event	Day 1 through discharge
Urinary 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

Trial Locations

Locations (1)

Lexicon Investigational Site; 🇺🇸 Madison, Wisconsin, United States