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NCT01656018 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01656018 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 4 participants.
The verdict
NCT01656018, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics (what the medication does to the body) of TMC278 long acting (slowly effective after initial dosage and maintaining its effects over a long period of time) when administered as an intramuscular (ie, in to the muscle) injection in adult participants who are seronegative for human immunodeficiency virus type 1 (HIV-1).
Interventions
- DRUG TMC278, Long acting (LA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2012-11 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01656018
The ClinicalTrials.gov registry entry for NCT01656018 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 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 1 intervention - of which TMC278, Long acting (LA) is the first listed.
NCT01656018 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01656018 about?
NCT01656018 is a clinical study titled "A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants". The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics (what the medication does to the body) of TMC278 long acting (slowly effective after initial dosage and maintaining its ...
What is the current status of trial NCT01656018?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2012-11. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01656018?
The interventions under investigation include: TMC278, Long acting (LA) (DRUG).
Who is sponsoring clinical trial NCT01656018?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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