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

NCT ID: NCT01818232

Last Updated: 2013-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-05-31

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[14C]-LX4211

400 mg LX4211 administered orally

Group Type: EXPERIMENTAL

[14C]-LX4211

Intervention Type: DRUG

Interventions

[14C]-LX4211

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ikenna Ogbaa, M.D.

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

Lexicon Investigational Site

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

LX4211.108

Identifier Type: -

Identifier Source: secondary_id

LX4211.1-108-NRM

Identifier Type: -

Identifier Source: org_study_id