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

Lexicon Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [14C]-LX4211

Study type

Interventional

Funder types

Industry

Identifiers

NCT01818232

LX4211.1-108-NRM

LX4211.108

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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