NCT02300350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 9, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

November 20, 2014

Last Update Submit

July 8, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • AUC

    Day 1-Day 7, Day 20-26

Secondary Outcomes (1)

  • Adverse Events

    Day 1-Day 26

Study Arms (3)

Treatment A

EXPERIMENTAL

0.5 mg single-dose oral digoxin administration

Drug: Treatment A digoxin

Treatment B

EXPERIMENTAL

400 mg oral LX4211 qd administration

Drug: Treatment B LX4211

Treatment C

EXPERIMENTAL

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

Drug: Treatment C Digoxin + 400 mg LX4211 administered concomitantly

Interventions

Treatment A digoxinDRUG

0.5 mg digoxin administered on Day 1 and Day 20

Treatment A
Treatment B LX4211DRUG

400 mg LX4211 administered daily on Day 14 through Day 25

Treatment B
Treatment C Digoxin + 400 mg LX4211 administered concomitantlyDRUG

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

Treatment C

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lexicon Investigational Site

Dallas, Texas, 75247, United States

Location

Study Officials

  • Suman Wason, MD

    Lexicon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 25, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 9, 2015

Record last verified: 2015-07

Locations

US(1)