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| ID | Type | Description | Link |
|---|---|---|---|
| 20200149 | Other Identifier | Amgen Study ID |
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The purpose of the study is to evaluate the effects of age and sex on the pharmacokinetics and safety of a single oral dose of 30 mg apremilast in healthy adults.
This is an open-label, parallel group study where eligible elderly adults (aged 65-85 years inclusive) and younger adults (aged 18-55 years inclusive) and who are matched to the elderly participants by sex and body mass index (BMI) (± 10%) will receive a single dose of 30 mg apremilast under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly: Apremilast 30 mg | Experimental | Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. |
|
| Younger: Apremilast 30 mg | Experimental | Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | One oral 30 mg dose of apremilast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Apremilast | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. AUC0-t was calculated using the linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing. | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
| AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Apremilast by Sex | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. AUC0-t was calculated using the linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing. | Day 1 predose 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 | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
| AUC From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast by Sex | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
| Maximum Observed Plasma Concentration (Cmax) of Apremilast | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) was any noxious, unintended, or untoward medical occurrence that appeared or worsened in a participant during the course of the study. It could have been a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a pre-existing condition) was considered an AE. |
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Inclusion Criteria:
Inclusion Criteria for elderly group
Inclusion Criteria for younger group:
Healthy male or female of any ethnic origin between the ages of 18 and 55 inclusive with a BMI between 18 and 35.
Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International | Lenexa | Kansas | 66219 | United States | ||
| Clinical Development Services |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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.
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.
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This study was conducted at two clinical research sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Young: Apremilast 30 mg | Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1. |
| FG001 | Elderly: Apremilast 30 mg | Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Young Males | Men aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1. |
| BG001 | Young Females | Women aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Apremilast | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. AUC0-t was calculated using the linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing. | The pharmacokinetic (PK) population included all participants who received apremilast and had evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
|
From first dose of apremilast up to 11 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Young Males | Men aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
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| ID | Term |
|---|---|
| C505730 | apremilast |
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| Maximum Observed Plasma Concentration of Apremilast by Sex | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | Day 1 predose 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 | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | Day 1 predose 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 by Sex | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | Day 1 predose 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) | Day 1 predose 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 by Sex | Day 1 predose 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 | Day 1 predose 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 of Apremilast by Sex | Day 1 predose 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 | Day 1 predose 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 by Sex | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
| From first dose of study drug up to 11 days |
| Dallas |
| Texas |
| 75247 |
| United States |
| BG002 | Elderly Males | Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. |
| BG003 | Elderly Females | Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Elderly: Apremilast |
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. |
|
|
|
| Secondary | Number of Participants With Adverse Events | An adverse event (AE) was any noxious, unintended, or untoward medical occurrence that appeared or worsened in a participant during the course of the study. It could have been a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a pre-existing condition) was considered an AE. | Participants who received apremilast | Posted | Count of Participants | Participants | From first dose of study drug up to 11 days |
|
|
|
| Primary | AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Apremilast by Sex | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. AUC0-t was calculated using the linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing. | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
|
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
|
|
|
|
| Primary | AUC From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast by Sex | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
|
|
|
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| Primary | Maximum Observed Plasma Concentration (Cmax) of Apremilast | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
|
|
|
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| Primary | Maximum Observed Plasma Concentration of Apremilast by Sex | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
|
|
|
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| Primary | Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Median | Full Range | hours | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
|
|
|
|
| Primary | Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast by Sex | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Median | Full Range | hours | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
|
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|
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| Primary | Estimate of Terminal Elimination Half-life of Apremilast in Plasma (t1/2) | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Mean | Standard Deviation | hours | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
|
|
|
| Primary | Estimate of Terminal Elimination Half-life of Apremilast in Plasma by Sex | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Mean | Standard Deviation | hours | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
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| Primary | Apparent Total Plasma Clearance When Dosed Orally (CL/F) of Apremilast | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
|
|
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| Primary | Apparent Total Plasma Clearance When Dosed Orally of Apremilast by Sex | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
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| Primary | Apparent Total Volume of Distribution When Dosed Orally (Vz/F) of Apremilast | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
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| Primary | Apparent Total Volume of Distribution When Dosed Orally (Vz/F) of Apremilast by Sex | The PK population included all participants who received apremilast and had evaluable PK profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. |
|
|
|
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Young Females | Women aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1. | 0 | 10 | 1 | 10 |
| EG002 | Young (Total) | Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1. | 0 | 18 | 3 | 18 |
| EG003 | Elderly Males | Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. | 0 | 8 | 2 | 8 |
| EG004 | Elderly Females | Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. | 0 | 10 | 5 | 10 |
| EG005 | Elderly (Total) | Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. | 0 | 18 | 7 | 18 |
| EG006 | Overall Total | All study participants received a single oral dose of 30 mg apremilast on Day 1. | 0 | 36 | 10 | 36 |
| NAUSEA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| TOOTHACHE | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 15.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| PHLEBITIS | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Adverse event related to study drug |
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| Serious adverse events |
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| Serious adverse events related to study drug |
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| Discontinued due to adverse event |
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| Discontinued due to adverse event related to study drug |
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