DDI Study With Multiple-dose LX4211 and Single Dose Digoxin
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Treatment B LX4211
- Registration Number
- NCT02300350
- Lead Sponsor
- Lexicon Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment A Treatment A digoxin 0.5 mg single-dose oral digoxin administration Treatment B Treatment B LX4211 400 mg oral LX4211 qd administration Treatment C Treatment C Digoxin + 400 mg LX4211 administered concomitantly 0.5 mg single-dose oral digoxin administration + 400 mg oral LX4211 qd administration
- Primary Outcome Measures
Name Time Method AUC Day 1-Day 7, Day 20-26
- Secondary Outcome Measures
Name Time Method Adverse Events Day 1-Day 26
Trial Locations
- Locations (1)
Lexicon Investigational Site
🇺🇸Dallas, Texas, United States