Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01561963 · ClinicalTrials.gov registry record · Phase 1
A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast
A Phase 1 study of Healthy Subjects, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01561963: Completed Phase 1 study of Healthy Subjects, sponsored by Amgen.
NCT01561963 is a Phase 1 study of Healthy Subjects that has completed, run by Amgen. The registered enrollment target is 21 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01561963, a Phase 1 study of Healthy Subjects, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.
Primary Outcome
Plasma concentrations of apremilast were determined by means of a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometric (LC-MS/MS) assay.
Conditions Studied
Interventions
- DRUG Apremilast
- DRUG Rifampin Oral Capsules
- DRUG Rifampin IV Solution
Study Locations (1)
Kansas
- Quintiles - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2012-02-01 |
| Est. Completion | 2012-04-01 |
| Phase | Phase 1 |
What the finished NCT01561963 record still lists
NCT01561963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 3 interventions - of which Apremilast is the first listed.
NCT01561963 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT01561963 about?
NCT01561963 is a clinical study titled "A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast". The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.
What is the current status of trial NCT01561963?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2012-02-01. Estimated completion is 2012-04-01.
What conditions does trial NCT01561963 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT01561963?
The interventions under investigation include: Apremilast (DRUG), Rifampin Oral Capsules (DRUG), Rifampin IV Solution (DRUG).
Who is sponsoring clinical trial NCT01561963?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01561963 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Subjects
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01561963's enrollment target sits among peer trials
21 55th of 69 higher than 15 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects 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
-
Phase I Study of ICP-332 in Healthy Subjects
RECRUITING · Phase 1
-
A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects
RECRUITING · Phase 1
-
Phase 1 Study of Intravaginal KB15A
RECRUITING · Phase 1
-
A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations
COMPLETED · Phase 1
-
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®
COMPLETED · Phase 1
-
A Single Oral Dose Study to Compare the Bioavailability Between Two Different Tablet Formulations and Assess if There is a Food Effect With the New Formulation
COMPLETED · Phase 1
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
- NCT02447874 · 21 participants · Phase 1
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
- NCT03826992 · 21 participants · Phase 1
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
- NCT04107077 · 21 participants · Phase 2
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
- NCT04158635 · 21 participants · Phase 1
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
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