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

NCT01818232 | Completed Phase 1

• 2 other identifiers: LX4211.1-108-NRMLX4211.108
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

[14C]-LX4211

EXPERIMENTAL

400 mg LX4211 administered orally

Drug: [14C]-LX4211

Interventions

[14C]-LX4211 DRUG

[14C]-LX4211

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (1)

Lexicon Investigational Site

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Ikenna Ogbaa, M.D.

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 26, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (1)