DDI Study With Multiple-dose LX4211 and Single Dose Digoxin
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 4/21/2016 |
Start Date: | October 2014 |
End Date: | December 2014 |
A Phase 1, Single-center, Open-label, Two-period, Single-sequence, Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose LX4211 on the Pharmacokinetics of Single-dose Digoxin (Lanoxin®), a Sensitive P-glycoprotein (P-gp) Substrate, in Healthy Male and Female Subjects
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.
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.
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
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