Healthy Volunteer
Conditions
Keywords
Apremilast, pharmacokinetic, safety, Pharmacokinetics and safety in healthy volunteer subjects
Brief summary
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.
Detailed description
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.
Interventions
DRUGApremilast
One oral 30 mg dose of apremilast
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) 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. | 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. |
| AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) 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. | 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. |
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) 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. | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. |
| AUC From Time Zero Extrapolated to Infinity (AUC0-∞) 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. | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. |
| Maximum Observed Plasma Concentration (Cmax) 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. | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. |
| Maximum Observed Plasma Concentration 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. | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. |
| Time to Maximum Observed Plasma Concentration (Tmax) 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. | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. |
| Time to Maximum Observed Plasma Concentration (Tmax) 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. | The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL. |
| 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. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | From first dose of study drug up to 11 days | 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at two clinical research sites in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Young Males Men aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1. | 8 |
| Young Females Women aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1. | 10 |
| Elderly Males Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. | 8 |
| Elderly Females Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. | 10 |
| Total | 36 |
Baseline characteristics
| Characteristic | Elderly Males | Elderly Females | Total | Young Females | Young Males |
|---|---|---|---|---|---|
| Age, Continuous | 70.4 years STANDARD_DEVIATION 3.62 | 70.6 years STANDARD_DEVIATION 4.72 | 52.4 years STANDARD_DEVIATION 19.23 | 35.2 years STANDARD_DEVIATION 7.19 | 33.3 years STANDARD_DEVIATION 7.48 |
| Body Mass Index (BMI) | 26.3 kg/m^2 STANDARD_DEVIATION 2.69 | 27.1 kg/m^2 STANDARD_DEVIATION 2.42 | 26.9 kg/m^2 STANDARD_DEVIATION 2.47 | 27.5 kg/m^2 STANDARD_DEVIATION 2.59 | 26.6 kg/m^2 STANDARD_DEVIATION 2.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 10 Participants | 34 Participants | 8 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 2 Participants | 11 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 8 Participants | 24 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Female | 0 Participants | 10 Participants | 20 Participants | 10 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 0 Participants | 16 Participants | 0 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 8 | 1 / 10 | 3 / 18 | 2 / 8 | 5 / 10 | 7 / 18 | 10 / 36 |
| serious Total, serious adverse events | 0 / 8 | 0 / 10 | 0 / 18 | 0 / 8 | 0 / 10 | 0 / 18 | 0 / 36 |
Outcome results
Primary
Apparent Total Plasma Clearance When Dosed Orally (CL/F) of Apremilast
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | Apparent Total Plasma Clearance When Dosed Orally (CL/F) of Apremilast | 10.4 L/hr | Geometric Coefficient of Variation 28.7 |
| Elderly: Apremilast | Apparent Total Plasma Clearance When Dosed Orally (CL/F) of Apremilast | 9.03 L/hr | Geometric Coefficient of Variation 41.8 |
Primary
Apparent Total Plasma Clearance When Dosed Orally of Apremilast by Sex
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | Apparent Total Plasma Clearance When Dosed Orally of Apremilast by Sex | 11.2 L/hr | Geometric Coefficient of Variation 24.8 |
| Elderly: Apremilast | Apparent Total Plasma Clearance When Dosed Orally of Apremilast by Sex | 8.57 L/hr | Geometric Coefficient of Variation 39.1 |
Primary
Apparent Total Volume of Distribution When Dosed Orally (Vz/F) of Apremilast
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | Apparent Total Volume of Distribution When Dosed Orally (Vz/F) of Apremilast | 136 liters | Geometric Coefficient of Variation 38.9 |
| Elderly: Apremilast | Apparent Total Volume of Distribution When Dosed Orally (Vz/F) of Apremilast | 115 liters | Geometric Coefficient of Variation 35.3 |
Primary
Apparent Total Volume of Distribution When Dosed Orally (Vz/F) of Apremilast by Sex
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | Apparent Total Volume of Distribution When Dosed Orally (Vz/F) of Apremilast by Sex | 128 liters | Geometric Coefficient of Variation 30.7 |
| Elderly: Apremilast | Apparent Total Volume of Distribution When Dosed Orally (Vz/F) of Apremilast by Sex | 123 liters | Geometric Coefficient of Variation 43.4 |
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.
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast | 2900 h*ng/mL | Geometric Coefficient of Variation 28.7 |
| Elderly: Apremilast | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast | 3323 h*ng/mL | Geometric Coefficient of Variation 41.8 |
Comparison: To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.90% CI: [94.1, 135]
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.
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The pharmacokinetic (PK) population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Apremilast | 2832 h*ng/mL | Geometric Coefficient of Variation 28.1 |
| Elderly: Apremilast | Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Apremilast | 3235 h*ng/mL | Geometric Coefficient of Variation 40.3 |
Comparison: To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.90% CI: [94.2, 135]
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.
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | AUC From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast by Sex | 2673 h*ng/mL | Geometric Coefficient of Variation 24.8 |
| Elderly: Apremilast | AUC From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast by Sex | 3499 h*ng/mL | Geometric Coefficient of Variation 39.1 |
Comparison: To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.90% CI: [109, 157]
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.
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Apremilast by Sex | 2634 h*ng/mL | Geometric Coefficient of Variation 24.5 |
| Elderly: Apremilast | AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Apremilast by Sex | 3382 h*ng/mL | Geometric Coefficient of Variation 38.2 |
Comparison: To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.90% CI: [107, 154]
Primary
Estimate of Terminal Elimination Half-life of Apremilast in Plasma by Sex
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | Estimate of Terminal Elimination Half-life of Apremilast in Plasma by Sex | 8.06 hours | Standard Deviation 1.72 |
| Elderly: Apremilast | Estimate of Terminal Elimination Half-life of Apremilast in Plasma by Sex | 10.3 hours | Standard Deviation 2.76 |
Primary
Estimate of Terminal Elimination Half-life of Apremilast in Plasma (t1/2)
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | Estimate of Terminal Elimination Half-life of Apremilast in Plasma (t1/2) | 9.41 hours | Standard Deviation 2.65 |
| Elderly: Apremilast | Estimate of Terminal Elimination Half-life of Apremilast in Plasma (t1/2) | 9.15 hours | Standard Deviation 2.56 |
Primary
Maximum Observed Plasma Concentration (Cmax) of Apremilast
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | Maximum Observed Plasma Concentration (Cmax) of Apremilast | 302 ng/mL | Geometric Coefficient of Variation 26.8 |
| Elderly: Apremilast | Maximum Observed Plasma Concentration (Cmax) of Apremilast | 321 ng/mL | Geometric Coefficient of Variation 27.8 |
Comparison: To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.90% CI: [90.5, 123]
Primary
Maximum Observed Plasma Concentration of Apremilast by Sex
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Young: Apremilast | Maximum Observed Plasma Concentration of Apremilast by Sex | 299 ng/mL | Geometric Coefficient of Variation 16.6 |
| Elderly: Apremilast | Maximum Observed Plasma Concentration of Apremilast by Sex | 322 ng/mL | Geometric Coefficient of Variation 33.5 |
Comparison: To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.90% CI: [92.3, 126]
Primary
Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Young: Apremilast | Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast | 2.50 hours |
| Elderly: Apremilast | Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast | 2.50 hours |
Comparison: Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.p-value: 0.15390% CI: [0, 2]Wilcoxon rank-sum test
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.
Time frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Population: The PK population included all participants who received apremilast and had evaluable PK profiles.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Young: Apremilast | Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast by Sex | 2.5 hours |
| Elderly: Apremilast | Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast by Sex | 2.75 hours |
Comparison: Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.p-value: 0.16990% CI: [0, 2]Wilcoxon rank-sum test
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.
Time frame: From first dose of study drug up to 11 days
Population: Participants who received apremilast
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Young: Apremilast | Number of Participants With Adverse Events | Any adverse event | 2 Participants |
| Young: Apremilast | Number of Participants With Adverse Events | Adverse event related to study drug | 2 Participants |
| Young: Apremilast | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Young: Apremilast | Number of Participants With Adverse Events | Serious adverse events related to study drug | 0 Participants |
| Young: Apremilast | Number of Participants With Adverse Events | Discontinued due to adverse event | 0 Participants |
| Young: Apremilast | Number of Participants With Adverse Events | Discontinued due to adverse event related to study drug | 0 Participants |
| Elderly: Apremilast | Number of Participants With Adverse Events | Discontinued due to adverse event related to study drug | 0 Participants |
| Elderly: Apremilast | Number of Participants With Adverse Events | Any adverse event | 1 Participants |
| Elderly: Apremilast | Number of Participants With Adverse Events | Serious adverse events related to study drug | 0 Participants |
| Elderly: Apremilast | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Elderly: Apremilast | Number of Participants With Adverse Events | Adverse event related to study drug | 1 Participants |
| Elderly: Apremilast | Number of Participants With Adverse Events | Discontinued due to adverse event | 0 Participants |
| Elderly Males | Number of Participants With Adverse Events | Serious adverse events related to study drug | 0 Participants |
| Elderly Males | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Elderly Males | Number of Participants With Adverse Events | Discontinued due to adverse event | 0 Participants |
| Elderly Males | Number of Participants With Adverse Events | Adverse event related to study drug | 0 Participants |
| Elderly Males | Number of Participants With Adverse Events | Discontinued due to adverse event related to study drug | 0 Participants |
| Elderly Males | Number of Participants With Adverse Events | Any adverse event | 2 Participants |
| Elderly Females | Number of Participants With Adverse Events | Serious adverse events | 0 Participants |
| Elderly Females | Number of Participants With Adverse Events | Discontinued due to adverse event related to study drug | 0 Participants |
| Elderly Females | Number of Participants With Adverse Events | Adverse event related to study drug | 1 Participants |
| Elderly Females | Number of Participants With Adverse Events | Any adverse event | 5 Participants |
| Elderly Females | Number of Participants With Adverse Events | Serious adverse events related to study drug | 0 Participants |
| Elderly Females | Number of Participants With Adverse Events | Discontinued due to adverse event | 0 Participants |