CClinicalTrials.gg
CompletedNCT01818232AMEUpdated Jun 18, 2013

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

A Phase 1 interventional study of [14C]-LX4211 in Healthy, sponsored by Lexicon Pharmaceuticals. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-18.

Sponsored by Lexicon Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Lexicon Pharmaceuticals is the lead sponsor of 60 studies on the registry; none are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    [14C]-LX4211

    400 mg LX4211 administered orally

    Drug: [14C]-LX4211

Interventions

  • Drug[14C]-LX4211
06

What researchers measure

Primary outcomes

  1. Area Under Curve (AUC)

    Time frame: Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose

Secondary outcomes

  1. Number of subjects experiencing an adverse event

    Time frame: Day 1 through discharge

  2. Urinary recovery of radioactivity

    Time frame: predose through 24 hours

  3. Fecal recovery of radioactivity

    Time frame: predose through 24 hours

  4. Whole blood and plasma concentration of total radioactivity

    Time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose

07

Study locations

1 site
  • Lexicon Investigational Site
    Madison, Wisconsin 53704, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01818232
Lead sponsor
Lexicon Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 26, 2013
Start date
Mar 2013
Primary completion
May 2013
Completion
May 2013
Last update
Jun 18, 2013

Study contacts

Ikenna Ogbaa, M.D.
study director · Lexicon Pharmaceuticals, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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