Phase 1
N=21
A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast
Healthy Subjects
Bottom Line
View on ClinicalTrials.gov: NCT01561963 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUCt) of Apremilast — 3070; 2940; 850 ng*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Apremilast (Drug); Rifampin Oral Capsules (Drug); Rifampin IV Solution (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUCt) of Apremilast |
3070; 2940; 850 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC∞) of Apremilast |
3120; 2980; 869 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Apremilast |
290; 331; 166 | — |
| PRIMARY Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast |
2.00; 1.50; 1.00 | 0.2656 |
| PRIMARY Estimate of the Terminal Elimination Half-life (T1/2) of Apremilast in Plasma |
8.12; 7.35; 6.13 | — |
| PRIMARY Apparent Total Plasma Clearance (CL/F) of Apremilast |
9.60; 10.1; 34.5 | — |
| PRIMARY Apparent Volume of Distribution (Vz/F) of Apremilast |
112; 107; 305 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy male or female subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 18 and 33
Exclusion Criteria
- Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, allergic or other major disorders.
- Use of any prescribed or non-prescribed systemic or topical medication (including vitamins and herbal medicines, e.g. St. John's Wort) within 30 days of the first dose, unless an exception is granted by the sponsor.
- Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
- Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration
Data sourced from ClinicalTrials.gov (NCT01561963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.