Clinical trial NCT02300350: DDI Study With Multiple-dose LX4211 and Single Dose Digoxin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-11-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: AUC
timeFrame: Day 1-Day 7, Day 20-26
Secondary outcomes:
measure: Adverse Events
timeFrame: Day 1-Day 26
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Lexicon Investigational Site
state: Texas
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Suman Wason, MD
role: STUDY_DIRECTOR
References: