Ignite Creation Date:
2024-05-06 @ 8:23 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02729467
Status:
COMPLETED
Last Update Posted:
2016-08-18
First Post:
2016-03-18
Brief Title:
A Study to Assess the Effects of Itraconazole and Rifampicin on the Single-Dose Pharmacokinetics of JNJ-53718678 in Healthy Adults
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
An Open-Label Fixed-Sequence Study to Assess the Effects of Itraconazole and Rifampicin on the Single-Dose Pharmacokinetics of JNJ-53718678 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2016-08
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 assess the effects of itraconazole a strong cytochrome P CYP3A4 and p-glycoprotein PgP inhibitor and rifampicin a CYP3A4 uridine 5-diphospho-glucuronosyltransferase UGT and PgP inducer and an inhibitor of organic anion-transporting polypeptide OATP on the single-dose pharmacokinetics PK of JNJ-53718678 in healthy adult participants
Detailed Description:
This is a single-center open-label fixed sequence Phase 1 study in healthy adult participants to study the effects of itraconazole and rifampicin on the pharmacokinetics safety and tolerability of a single dose of JNJ-53718678 This study will be conducted in 2 separate panels with 14 participants in Panel 1 and 16 participants in Panel 2 The study consists of following phases Screening 28 days Treatment phase 11 days and Follow-up 10 to 14 days after the last study drug intake Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment Participants will be assessed for safety and tolerability throughout the study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 53718678RSV1006 | OTHER | Janssen Research Development LLC | None |