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DDI Study With Multiple-dose LX4211 and Single Dose Digoxin

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ClinicalTrials.gov Identifier: NCT02300350
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Treatment A digoxin Drug: Treatment B LX4211 Drug: Treatment C Digoxin + 400 mg LX4211 administered concomitantly Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arm Intervention/treatment
Experimental: Treatment A
0.5 mg single-dose oral digoxin administration
Drug: Treatment A digoxin
0.5 mg digoxin administered on Day 1 and Day 20

Experimental: Treatment B
400 mg oral LX4211 qd administration
Drug: Treatment B LX4211
400 mg LX4211 administered daily on Day 14 through Day 25

Experimental: Treatment C
0.5 mg single-dose oral digoxin administration + 400 mg oral LX4211 qd administration
Drug: Treatment C Digoxin + 400 mg LX4211 administered concomitantly
0.5 mg Digoxin + 400 mg LX4211 administered concomitantly on Day 20




Primary Outcome Measures :
  1. AUC [ Time Frame: Day 1-Day 7, Day 20-26 ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Day 1-Day 26 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300350


Locations
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United States, Texas
Lexicon Investigational Site
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.

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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02300350     History of Changes
Other Study ID Numbers: LX4211.1-114-NRM
LX4211.114 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Hypoglycemic Agents