NCT02300363

DDI Study With Multiple-dose LX4211 and Single Dose Rosuvastatin

A Phase 1, Single-center, Open-label, 2-period, Single-sequence, Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose LX4211 on the Pharmacokinetics of Single-dose Rosuvastatin (Crestor®), a Sensitive Breast Cancer Resistance Protein (BCRP) 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 (2 × 200-mg tablets qd × 7 days) on the PK of single-dose rosuvastatin (1 × 10-mg tablet) in healthy male and female subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Treatment A (rosuvastatin)	10 mg rosuvastatin administered on Day 1 and Day 13
DRUG	Treatment B (LX4211)	400 mg LX4211 administered on Day 7 through Day 13
DRUG	Treatment C (rosuvastatin + 400 mg LX4211 administered concomitantly)	10 mg rosuvastatin + 400 mg LX4211 administered concomitantly on Day 13

Timeline

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

Locations

1 site across 1 country: United States