A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/23/2016 |
| Start Date: | February 2012 |
| End Date: | April 2012 |
A Phase 1, Open-label, Three-period, Fixed-sequence Study to Evaluate the Effects of Rifampin on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Subjects
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.
affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.
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
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