A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01561963
First received: March 21, 2012
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Apremilast
Drug: Rifampin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Pharmacokinetic measures: area under the plasma concentration-time curve [ Time Frame: Up to 2 days post dose ] [ Designated as safety issue: No ]
    Pharmacokinetic measures: area under the plasma concentration-time curve

  • Pharmacokinetic measures: area under the maximum observed plasma concentration [ Time Frame: Up to 2 days post dose ] [ Designated as safety issue: No ]
    Pharmacokinetic measures: area under the maximum observed plasma concentration


Enrollment: 21
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apremilast and Rifampin
  • A single oral dose of 30 mg apremilast on Day 1 in Period 1;
  • A single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5 in Period 2;
  • Once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20 in Period 3.
Drug: Apremilast

Each subject will receive the following 3 treatments in the same fixed sequence during the study (the study days are numbered sequentially across all 3 periods):

  • A single oral dose of 30 mg apremilast on Day 1 in Period 1;
  • A single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5 in Period 2;
  • Once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20 in Period 3.
Other Name: CC-10004
Drug: Rifampin
  • A single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5 in Period 2;
  • Once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20 in Period 3.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561963

Locations
United States, Kansas
Quintiles
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Maria Palmisano, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01561963     History of Changes
Other Study ID Numbers: CC-10004-CP-025
Study First Received: March 21, 2012
Last Updated: October 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Apremilast
drug interaction
pharmacokinetics

Additional relevant MeSH terms:
Rifampin
Apremilast
Thalidomide
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Phosphodiesterase Inhibitors
Central Nervous System Agents
Immunosuppressive Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014