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DDI Study With Multiple-dose LX4211 and Single Dose Digoxin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 20, 2014
First Posted Date  ICMJE November 25, 2014
Last Update Posted Date July 9, 2015
Study Start Date  ICMJE October 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
AUC [ Time Frame: Day 1-Day 7, Day 20-26 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
Adverse Events [ Time Frame: Day 1-Day 26 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DDI Study With Multiple-dose LX4211 and Single Dose Digoxin
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Treatment A digoxin
    0.5 mg digoxin administered on Day 1 and Day 20
  • Drug: Treatment B LX4211
    400 mg LX4211 administered daily on Day 14 through Day 25
  • Drug: Treatment C Digoxin + 400 mg LX4211 administered concomitantly
    0.5 mg Digoxin + 400 mg LX4211 administered concomitantly on Day 20
Study Arms  ICMJE
  • Experimental: Treatment A
    0.5 mg single-dose oral digoxin administration
    Intervention: Drug: Treatment A digoxin
  • Experimental: Treatment B
    400 mg oral LX4211 qd administration
    Intervention: Drug: Treatment B LX4211
  • Experimental: Treatment C
    0.5 mg single-dose oral digoxin administration + 400 mg oral LX4211 qd administration
    Intervention: Drug: Treatment C Digoxin + 400 mg LX4211 administered concomitantly
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2014)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02300350
Other Study ID Numbers  ICMJE LX4211.1-114-NRM
LX4211.114 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lexicon Pharmaceuticals
Study Sponsor  ICMJE Lexicon Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.
PRS Account Lexicon Pharmaceuticals
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP