Clinical trial NCT01818232: Study to Determine the Absorption, Metabolism, and Excretion of [14C]LX4211 in Healthy Male Subjects
Official title: A Phase 1, Open-label, Nonrandomized, Single Dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-LX4211, Following Oral Administration, in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-03-26
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Area Under Curve (AUC)
timeFrame: Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose
Secondary outcomes:
measure: Number of subjects experiencing an adverse event
timeFrame: Day 1 through discharge
measure: Urinary recovery of radioactivity
timeFrame: predose through 24 hours
measure: Fecal recovery of radioactivity
timeFrame: predose through 24 hours
measure: Whole blood and plasma concentration of total radioactivity
timeFrame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose
Other outcomes:
Locations:
city: Madison
country: United States
facility: Lexicon Investigational Site
state: Wisconsin
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Ikenna Ogbaa, M.D.
role: STUDY_DIRECTOR
References: