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NCT03127189 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
NCT03127189: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT03127189 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 110 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03127189, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
Study 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.
Primary Outcome
The Cmax is the maximum observed plasma concentration.
Interventions
- DRUG Rilpivirine
- DRUG Rilpivirine Long-acting Parenteral Formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2017-04-20 |
| Est. Completion | 2018-04-10 |
| Phase | Phase 1 |
What the finished NCT03127189 record still lists
NCT03127189 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% higher).
The record links to 0 conditions, and to 2 interventions - of which Rilpivirine is the first listed.
NCT03127189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03127189 about?
NCT03127189 is a clinical study titled "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". 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.
What is the current status of trial NCT03127189?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2017-04-20. Estimated completion is 2018-04-10.
What interventions are being tested in trial NCT03127189?
The interventions under investigation include: Rilpivirine (DRUG), Rilpivirine Long-acting Parenteral Formulation (DRUG).
Who is sponsoring clinical trial NCT03127189?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03127189's enrollment target sits among peer trials
110 514th of 2000 higher than 1,479 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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