Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02877225 · ClinicalTrials.gov registry record · Phase 1

Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule

A Phase 1 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
103
Enrollment target

NCT02877225: Completed Phase 1 study, sponsored by Janssen Research & Development.

NCT02877225 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 103 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02877225, a Phase 1 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
103 participants
Enrollment target

Study Summary

The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.

Primary Outcome

Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.

Interventions

  • DRUG Ibrutinib
  • DRUG IMBRUVICA

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2016-08-29
Est. Completion 2016-11-11
Phase Phase 1
Janssen Research & Development

593 total trials

What the finished NCT02877225 record still lists

NCT02877225 is an interventional study that assigns participants to a tested intervention. The registered 103 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 (72% higher).

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

NCT02877225 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02877225 about?

NCT02877225 is a clinical study titled "Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule". The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.

What is the current status of trial NCT02877225?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2016-08-29. Estimated completion is 2016-11-11.

What interventions are being tested in trial NCT02877225?

The interventions under investigation include: Ibrutinib (DRUG), IMBRUVICA (DRUG).

Who is sponsoring clinical trial NCT02877225?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02877225's enrollment target sits among peer trials

103 541st of 2000 higher than 1,458 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04690348 · 103 participants · Phase 2

    Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

  • NCT05282277 · 103 participants · Phase 4

    Examining the Effects of Estradiol on Neural and Molecular Response to Reward

  • NCT05566769 · 103 participants · NA

    Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD

  • NCT05834478 · 103 participants · Phase 3

    Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT02877225, the US trial registry maintained by the National Library of Medicine. NCT02877225 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.