NCT02300350

DDI Study With Multiple-dose LX4211 and Single Dose Digoxin

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-11-25
• Last updated: 2015-07-09

Locations

1 site across 1 country: United States