Healthy
Conditions
Brief summary
This study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple dose LX4211 (400 mg administered as 2 × 200-mg tablets qd × 12 days) on the PK of single-dose digoxin (2 × 0.25-mg tablets) in healthy male and female subjects.
Interventions
DRUGTreatment A digoxin
0.5 mg digoxin administered on Day 1 and Day 20
DRUGTreatment B LX4211
400 mg LX4211 administered daily on Day 14 through Day 25
DRUGTreatment C Digoxin + 400 mg LX4211 administered concomitantly
0.5 mg Digoxin + 400 mg LX4211 administered concomitantly on Day 20
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult subjects ≥18 to ≤55 years of age * Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm * Body mass index (BMI) ≥18 and ≤32 kg/sq m * Willing and able to provide written informed consent
Exclusion criteria
* Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results * History of clinically significant arrhythmias * History of cardiac arrhythmias or palpitations associated with presyncope, syncope, or a family history of sudden cardiac death * Use of any medications or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study * Receipt of any investigational agent or study drug within 30 days prior to Screening * Receipt of any protein- or antibody-based therapeutic agents within 3 months prior to Screening * Prior exposure to LX4211 * Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study * History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211 or digoxin * Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211 or digoxin * History of any major surgery within 6 months or anticipated surgery prior to Day 1 * History of any clinically significant hypoglycemia or hyperglycemia * History of renal disease, or significantly abnormal kidney function test at Screening * History of hepatic disease, or significantly abnormal liver function tests at Screening * History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality * History of any active infection within 14 days prior to Day 1 * History of alcohol or substance abuse within 2 years prior to Screening * Positive hepatitis panel * Donation or loss of \>500 mL of blood or blood product within 3 months prior to Screening * Women who are breastfeeding or are planning to become pregnant during the study, or women who have a positive serum pregnancy test * Positive urine glucose at Screening * Positive urine screen for drugs of abuse and cotinine at Screening, Day -1, or Day 13 * Inability or difficulty swallowing whole tablets * Unable or unwilling to cooperate with the Investigator for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC | Day 1-Day 7, Day 20-26 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events | Day 1-Day 26 |
Countries
United States
Outcome results
None listed