DDI Study With Multiple-dose LX4211 and Single Dose Digoxin

NCT ID: NCT02300350

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2014-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

0.5 mg single-dose oral digoxin administration

Group Type: EXPERIMENTAL

Treatment A digoxin

Intervention Type: DRUG

0.5 mg digoxin administered on Day 1 and Day 20

Treatment B

400 mg oral LX4211 qd administration

Group Type: EXPERIMENTAL

Treatment B LX4211

Intervention Type: DRUG

400 mg LX4211 administered daily on Day 14 through Day 25

Treatment C

0.5 mg single-dose oral digoxin administration + 400 mg oral LX4211 qd administration

Group Type: EXPERIMENTAL

Treatment C Digoxin + 400 mg LX4211 administered concomitantly

Intervention Type: DRUG

0.5 mg Digoxin + 400 mg LX4211 administered concomitantly on Day 20

Interventions

Treatment A digoxin

0.5 mg digoxin administered on Day 1 and Day 20

Intervention Type: DRUG

Treatment B LX4211

400 mg LX4211 administered daily on Day 14 through Day 25

Intervention Type: DRUG

Treatment C Digoxin + 400 mg LX4211 administered concomitantly

0.5 mg Digoxin + 400 mg LX4211 administered concomitantly on Day 20

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suman Wason, MD

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

Lexicon Investigational Site

Dallas, Texas, United States

Countries

United States

Other Identifiers

LX4211.114

Identifier Type: OTHER

Identifier Source: secondary_id

LX4211.1-114-NRM

Identifier Type: -

Identifier Source: org_study_id