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NCT02729467 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effects of Itraconazole and Rifampicin on the Single-Dose Pharmacokinetics of JNJ-53718678 in Healthy Adults
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT02729467: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02729467 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02729467, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effects of itraconazole, a strong cytochrome P (CYP)3A4 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.
Primary Outcome
The Cmax is the maximum observed analyte concentration after the JNJ-53718678 doses on Day 1, Day 4 (Panel 2 only) and Day 9.
Interventions
- DRUG Itraconazole
- DRUG Rifampicin
- DRUG JNJ-53718678
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2016-03 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02729467 record still lists
NCT02729467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 3 interventions - of which Itraconazole is the first listed.
NCT02729467 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02729467 about?
NCT02729467 is a clinical study titled "A Study to Assess the Effects of Itraconazole and Rifampicin on the Single-Dose Pharmacokinetics of JNJ-53718678 in Healthy Adults". The purpose of this study is to assess the effects of itraconazole, a strong cytochrome P (CYP)3A4 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 ...
What is the current status of trial NCT02729467?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2016-03. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02729467?
The interventions under investigation include: Itraconazole (DRUG), Rifampicin (DRUG), JNJ-53718678 (DRUG).
Who is sponsoring clinical trial NCT02729467?
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 NCT02729467's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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