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Study Complete
Sponsor ID
CC-10004-CP-025

A drug-Drug interaction study to evaluate the effect of rifampin on the pharmacokinetics of apremilast

Sponsor ID
CC-10004-CP-025
Clinicaltrials.gov ID
NCT01561963
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
21
Additional Study Details

Protocol Summary

Primary Outcome Measures

Pharmacokinetic measures: area under the plasma concentration-time curve

Timeframe: Up to 2 days post dose

Pharmacokinetic measures: area under the maximum observed plasma concentration

Timeframe: Up to 2 days post dose

Secondary Outcome Measures
Not Available

Locations

Location
Status
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Location
Quintiles
Overland Park, KS, United States, 66211
Status
Recruiting
Study Info
Age
18 - 55 Years
Condition
  • Healthy Subjects
    • Sex
    All
    Trial Dates
    Feb 2012 - Apr 2012
    Inclusion and Exclusion 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