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DDI Study With Multiple-dose LX4211 and Single Dose Digoxin

NCT02300350 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-07-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Suman Wason, MD · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02300350 on ClinicalTrials.gov