Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT02611518
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2015-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Interaction Study Between JNJ-54861911 and Transporter Substrates Rosuvastatin and Metformin in Healthy Participants
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
A Phase 1, 2-Panel, Open-Label, Fixed-Sequence Study in Healthy Adult Subjects to Investigate the Pharmacokinetic Interaction Between JNJ-54861911 and Transporter Substrates Rosuvastatin and Metformin
Status:
COMPLETED
Status Verified Date:
2025-01
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:
The purpose of this study is to look at how taking JNJ-54861911 every day will effect the amount of rosuvastatin or metformin in your blood after taking only a single dose of either one.
Detailed Description:
This is an open-label (all people know the identity of the intervention), single-center, fixed sequence, 2-panel study in a total of 32 healthy adult participants (16 participants per panel). The study consists of 3 phases: a Screening Phase of approximately 3 weeks (Days -22 to -2), an Open-Label Treatment Phase consisting of a single 19 day Treatment Period for Panel 1 (Days -1 to 18) or a single 18 day Treatment Period for Panel 2 (Days -1 to 17) and a Follow-up Phase of 5 to 7 days. In Panel 1, each participant will be administered a single oral dose of 10 milligram (mg) rosuvastatin on Day 1 and Day 14. Participants will receive JNJ-54861911 at a dose of 25 mg once daily from Day 8 until Day 17. In Panel 2, each participant will be administered a single oral dose of 500 mg metformin on Day 1 and Day 14. Participants will receive JNJ-54861911 at a dose of 25 mg once daily from Day 8 until Day 16. Participants' safety will be monitored throughout the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|---|
| 54861911ALZ1012 | OTHER | Janssen Research & Development, LLC | View |