Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-27 @ 7:12 AM
Study NCT ID:
NCT02300350
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2014-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DDI Study With Multiple-dose LX4211 and Single Dose Digoxin
Sponsor:
Lexicon Pharmaceuticals
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| LX4211.114 | OTHER | Lexicon Pharmaceuticals, Inc. | View |