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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01634191
First Posted: July 6, 2012
Last Update Posted: March 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene Corporation
July 3, 2012
July 6, 2012
March 28, 2016
February 2012
March 2012   (Final data collection date for primary outcome measure)
  • AUC0-24 [ Time Frame: Up to 4 days ]
    Area under the plasma concentration-time curve from time zero to 24 hours post dose
  • Cmax [ Time Frame: Up to 4 days ]
    Cmax: Maximum observed plasma concentration
  • Tmax [ Time Frame: Up to 4 days ]
    Tmax: Time to maximum observed plasma concentration
  • AUC0-t [ Time Frame: Up to 4 days ]
    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 ]
    AUC0-∞: Area under the plasma concentration-time curve from time zero extrapolated to infinity
  • t1/2 [ Time Frame: Up to 4 days ]
    t1/2: Estimate of the terminal elimination half-life in plasma
Same as current
Complete list of historical versions of study NCT01634191 on ClinicalTrials.gov Archive Site
Number or participants with adverse events [ Time Frame: Up to 11 days ]
Safety will be evaluated by regular adverse event monitoring, clinical laboratory tests, physical exams, ECGs, and vital signs.
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Apremilast (CC-10004) in Healthy Elderly Subjects
An Open-Label, Single-Dose Study to Evaluate the Effects of Age and Sex on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Subjects
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.
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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Healthy Volunteer
Drug: Apremilast
One oral 30 mg dose of apremilast
Other Name: CC-10004
  • Experimental: Apremilast (A: 30mg dose of apremilast in Elderly subjects)
    A: One oral 30 mg dose of apremilast in Elderly subjects
    Intervention: Drug: Apremilast
  • Experimental: Apremilast (B: 30mg dose of apremilast in younger subjects)
    One oral 30 mg dose of apremilast in younger subjects
    Intervention: Drug: Apremilast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
April 2012
March 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01634191
CC-10004-CP-024
No
Not Provided
Not Provided
Celgene Corporation
Celgene Corporation
Not Provided
Study Chair: Maria Palmisano, MD Celgene Corporation
Celgene Corporation
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP