Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults

NCT01634178 | Completed Phase 1 Results

• 2 other identifiers: CC-10004-CP-02220200148
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the effects of a high fat meal on the pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.

Conditions

Healthy Volunteer

Keywords

Apremilast,; pharmacokinetic; safety; Safety and pharmacokinetics in healthy volunteer subjects

Outcome Measures

Primary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax) of Apremilast

  Plasma concentrations of apremilast were determined by using a validated liquid chromatography-tandem mass spectrometry assay.

  Day 1 of each treatment period at pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.

• Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast

  Plasma concentrations of apremilast were determined by using a validated liquid chromatography-tandem mass spectrometry assay.

  Day 1 of each treatment period at pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.

• Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Apremilast

  Plasma concentrations of apremilast were determined by using a validated liquid chromatography-tandem mass spectrometry assay. AUC0-t was calculated using the linear trapezoidal method (linear up log down) when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing.

  Day 1 of each treatment period at pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.

• Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast

  Plasma concentrations of apremilast were determined by using a validated liquid chromatography-tandem mass spectrometry assay.

  Day 1 of each treatment period at pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.

• Estimate of Terminal Elimination Half-life of Apremilast in Plasma (t1/2)

  Plasma concentrations of apremilast were determined by using a validated liquid chromatography-tandem mass spectrometry assay.

  Day 1 of each treatment period at pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.

• Apparent Total Plasma Clearance When Dosed Orally (CL/F) of Apremilast

  Plasma concentrations of apremilast were determined by using a validated liquid chromatography-tandem mass spectrometry assay.

  Day 1 of each treatment period at pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.

• Apparent Total Volume of Distribution When Dosed Orally (Vz/F) of Apremilast

  Plasma concentrations of apremilast were determined by using a validated liquid chromatography-tandem mass spectrometry assay.

  Day 1 of each treatment period at pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  From first dose of study drug in Period 1 up to 5 to 10 days after dosing in Period 2, approximately 20 days.

Study Arms (2)

Sequence 1: Apremilast Fasted / Fed

EXPERIMENTAL

In Period 1 participants will receive a single 30 mg apremilast tablet administered under fasted conditions and in Period 2 participants will receive a single 30 mg apremilast tablet administered after a high fat meal.

Drug: Apremilast

Sequence 2: Apremilast Fed / Fasted

EXPERIMENTAL

In Period 1 participants will receive a single 30 mg apremilast tablet administered after a high fat meal and in Period 2 participants will receive a single 30 mg apremilast tablet administered under fasted conditions.

Drug: Apremilast

Interventions

Apremilast DRUG

Tablet for oral administration

Also known as: CC-10004, Otezla®

Sequence 1: Apremilast Fasted / Fed; Sequence 2: Apremilast Fed / Fasted

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female subjects of any ethnic origin between ages of 18 and 65 inclusive with a body mass index (BMI) between 18 and 33.
• 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.
• All other females must have been surgically sterilized at least 6 months prior to screening or be postmenopausal (to be confirmed by lab tests).
• Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.

You may not qualify if:

• 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.
• 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 or 5 half-lives of that investigational drug, if known (whichever is longer).
• Subjects with known serum hepatitis, is a known carrier of hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody.
• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

PPD Development

Austin, Texas, 787844, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

apremilast

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 21, 2021
• Results First Posted: April 21, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (1)