Pharmacokinetics of Apremilast (CC-10004) in Healthy Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01634191
First received: July 3, 2012
Last updated: July 5, 2012
Last verified: June 2012
  Purpose

The purpose of the study is to evaluate the effects of age and sex on the pharmacokinetics, and the safety of a single oral dose of 30 mg of apremilast in healthy subjects.


Condition Intervention Phase
Healthy Volunteer
Drug: Apremilast
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: An Open-Label, Single-Dose Study to Evaluate the Effects of Age and Sex 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:
  • AUC0-24 [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]
    Area under the plasma concentration-time curve from time zero to 24 hours post dose

  • Cmax [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]
    Cmax: Maximum observed plasma concentration

  • Tmax [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]
    Tmax: Time to maximum observed plasma concentration

  • AUC0-t [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]
    AUC0-t: Area under the plasma concentration-time curve from time zero to time t, where t is the last measurable time point

  • AUC0-∞ [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]
    AUC0-∞: Area under the plasma concentration-time curve from time zero extrapolated to infinity

  • t1/2 [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]
    t1/2: Estimate of the terminal elimination half-life in plasma


Secondary Outcome Measures:
  • Number or participants with adverse events [ Time Frame: Up to 11 days ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by regular adverse event monitoring, clinical laboratory tests, physical exams, ECGs, and vital signs.


Enrollment: 36
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apremilast (A: 30mg dose of apremilast in Elderly subjects)
A: One oral 30 mg dose of apremilast in Elderly subjects
Drug: Apremilast
One oral 30 mg dose of apremilast
Other Name: CC-10004
Experimental: Apremilast (B: 30mg dose of apremilast in younger subjects)
One oral 30 mg dose of apremilast in younger subjects
Drug: Apremilast
One oral 30 mg dose of apremilast
Other Name: CC-10004

Detailed Description:

This is an open-label, parallel group study where eligible elderly subjects (aged 65-85 years inclusive) and younger subjects (aged 18-55 years inclusive) and who are matched to the elderly subjects by sex and BMI (± 10%) will receive a single dose of 30 mg apremilast under fasting conditions. The subjects will check into the study center on Day -1, will be dosed on Day 1, and discharged from the study center on Day 3 after all scheduled pharmacokinetic blood draws and safety evaluations.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion Criteria for elderly group

  1. Healthy male or female subjects of any ethnic origin between ages of 65 and 85 inclusive with a body mass index (BMI) between 18 and 35.
  2. Females must have been surgically sterilized at least 6 months prior to screening or be postmenopausal (to be confirmed by lab tests).
  3. Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.
  4. Elderly subjects with stable, chronic medical condition may be eligible if the condition is well-controlled and medications do not interfere with study procedures or pharmacokinetic interpretation

Inclusion Criteria for younger group:

  1. Healthy male or female of any ethnic origin between the ages of 18 and 55 inclusive with a BMI between 18 and 35.
  2. Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.
  3. Females who are able to become pregnant have a negative pregnancy test at screening and baseline, and must agree to use one of the following:

    • a highly effective form of contraception (ex. Non-oral hormonal, intrauterine device) OR
    • oral hormonal contraceptive plus one additional form of barrier contraception OR
    • two forms of barrier contraception These must be effective by the time of screening. For younger females who are not able to become pregnant, the conditions for the elderly females will apply.

Exclusion Criteria:

  1. Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent form, places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
  2. 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.
  3. Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
  4. Subjects with known serum hepatitis, is a known carrier of hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody.
  5. Subjects who have used prescription systemic or topical medications within 30 days of dosing, unless it is being used to treat a stable, chronic medical condition. This includes medication that is an inhibitor or inducer of P-glycoprotein transporter and CYP-3A4/5 used within 14 days of dosing.
  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: NCT01634191

Locations
United States, Kansas
PRA International
Lenexa, Kansas, United States, 66219
United States, Texas
Clinical Development Services
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Chair: Maria Palmisano, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01634191     History of Changes
Other Study ID Numbers: CC-10004-CP-024
Study First Received: July 3, 2012
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Apremilast
pharmacokinetic
safety
Pharmacokinetics and safety in healthy volunteer subjects

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

ClinicalTrials.gov processed this record on August 20, 2014