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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 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 110 participants.

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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.

Interventions

  • DRUG Rilpivirine
  • DRUG Rilpivirine Long-acting Parenteral Formulation

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2017-04-20
Est. Completion 2018-04-10
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT03127189

The ClinicalTrials.gov registry entry for NCT03127189 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Rilpivirine is the first listed.

NCT03127189 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.