Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-02 @ 12:04 PM
Study NCT ID:
NCT02595268
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2015-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effect of JNJ-63623872 on Pitavastatin in Healthy Participants
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, Sequential Study to Investigate the Effect of JNJ 63623872 on Pitavastatin in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2016-01
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 evaluate the effect of steady-state concentrations of JNJ-63623872 on the single-dose pharmacokinetics of pitavastatin in healthy participants.
Detailed Description:
This is a Phase 1, open-label (identity of study drug will be known to participant and study staff), sequential study in healthy volunteers to investigate the potential Pharmacokinetics (PK) effects of JNJ-872 on pitavastatin. The study consists of Screening Phase (28 days), Treatment Phase (Day 1 - Day 12), Follow up (10-14 days and 30-35 days after last study drug intake or drop). The total duration of the study will be approximately 2 months. Participants will sequentially receive the following treatment: a single oral dose of pitavastatin 1 milligram (mg) on Day 1; JNJ-63623872 600 mg twice daily on Days 4 through 12, with a single oral dose of pitavastatin 1 mg administered in the morning of Day 9. All study drug intakes will be taken orally, under fed conditions (within approximately 10 minutes after completion of a meal). Blood samples will be collected to assess pharmacokinetic parameters. Participants' safety will be monitored throughout the study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: