Ignite Creation Date:
2024-05-06 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03127189
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2017-03-15
Brief Title:
A Study to Investigate the Effect of Different Particle Sizes on the Single-dose Pharmacokinetics of Rilpivirine After Intramuscular Injection of a Long-acting Nanosuspension in Healthy Participants
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 1 Open-label Randomized Parallel-group Study in Healthy Subjects to Investigate the Effect of Different Particle Sizes on the Single-dose Pharmacokinetics of Rilpivirine After Intramuscular Injection of a Long-acting Nanosuspension
Status:
COMPLETED
Status Verified Date:
2018-08
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 main purpose of this study is to characterize the single-dose pharmacokinetics PK of rilpivirine RPV after intramuscular IM injection of rilpivirine long-acting parenteral formulation RPV LA nanosuspensions with different particle size distribution PSD in healthy adult participants
Detailed Description:
This is a phase 1 open-label all people know the identity of the intervention randomized study medication is assigned by chance parallel-group sequential study in healthy adult participants to characterize the single-dose pharmacokinetics PK of rilpivirine RPV after intramuscular IM injection of RPV LA nanosuspensions with different particle size distributions PSD in healthy adult participants A total of 110 healthy adult participants will be enrolled in this study The study will consist of 2 treatment sessions in a fixed sequential order Session 1- all participants will receive a single oral dose of rilpivirine 25 milligram mg as oral immediate release solution on Day 1 Session 2- the participants will be randomized in session 2 on Day 1 in a 11111 ratio to Treatments A B C D and E Each treatment group will receive a single IM injection of RPV LA on Day 1 of session 2 Session 1 and 2 will be separated by a washout period of at least 14 days The total study duration for each participant will be approximately 95 months Safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TMC278LAHTX1002 | OTHER | Janssen Research Development LLC | None |