DDI Study With Multiple-dose LX4211 and Single Dose Digoxin

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lexicon Pharmaceuticals
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Digoxin

Criteria

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