Healthy Volunteers
Conditions
Keywords
Apremilast, Healthy volunteers, Bioavailability, Food effect, Pharmacokinetic
Brief summary
The purpose of this study is to assess how much of apremilast is found in the blood unchanged when administered as an oral suspension compared to when it is administered as a tablet formulation. The effect of food on apremilast oral suspension will also be evaluated. In addition, information on the safety and tolerability of apremilast will be obtained.
Detailed description
This is a phase 1, open-label, randomized, three-period, six-sequence crossover study in healthy subjects. The study will consist of a screening phase, baseline (Day -1), three study periods, and a follow-up phone call. Each study period will be four days in duration (Day 1 through Day 4) followed by a five-day washout between doses. Eligible participants will be admitted into the study center on Day -1 of study Period 1 for baseline measurements. During each study period, participants will receive a single 30 mg oral dose of apremilast on Day 1 according to the assigned treatment sequence. Participants will be confined at the study center from Day 1 of study Period 1 through Day 4 of study Period 3, including the 5 day washout between doses. All participants will be discharged from the study center on Day 4 of study Period 3 following completion of required study procedures. A follow-up phone call will occur approximately four days after the discharge from the study center. The study will be conducted in compliance with International Conference on Harmonisation (ICH) Good Clinical Practices (GCPs).
Interventions
DRUGApremilast Tablet
30 mg tablet
DRUGApremilast Oral Suspension
30 mg oral suspension
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must satisfy ALL of the following criteria to be eligible for enrollment into the study: 1. Must understand and voluntarily sign a written Informed Consent (ICF) prior to any study-related procedures being performed. 2. Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules. 3. Male and female subjects of any race between 18 to 55 years of age (inclusive), and in good health as determined by the Investigator at the time of signing the informed consent document. 4. Have a Body Mass Index (BMI) between 18 and 33 kg/m\^2 (inclusive). 5. No clinically significant laboratory test results as determined by the investigator. 6. At the screening visit, must be afebrile, with supine systolic blood pressure (BP): 90 to 140 mmHg, supine diastolic BP: 50 to 90 mmHg, and pulse rate: 40 to 110 bpm. Eligibility criteria for vital signs performed during check-in and/or predose on Day 1 will be at the discretion of the Investigator. 7. Must have a normal or clinically acceptable 12-lead electrocardiogram (ECG). Subjects must have a QTcF value ≤ 450 msec. 8. Contraception Requirements: * Must comply with the following acceptable forms of contraception. All female of childbearing potential (FCBP) must use one of the approved contraceptive options as described below while taking apremilast and for at least 28 days after administration of the last dose of the apremilast. * At the time of study entry, and at any time during the study when a FCBP's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy All FCBP must have a negative pregnancy test at Visits 1 and 2. All FCBP subjects who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]); PLUS one of the following additional barrier methods: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex or non-latex condoms NOT made out of natural \[animal\] membrane \[for example, polyurethane\]) while on investigational product (IP) and for at least 28 days after the last dose of IP. 9. Must agree to refrain from donating sperm, blood or plasma (other than for this study) while participating in this study and for at least 28 days after the last dose of investigational product. 10. Subject is willing and able to adhere to the study visit schedule and other protocol requirements
Exclusion criteria
The presence of ANY of the following will exclude any healthy subject from enrollment into the study: 1. History of any clinically significant and relevant neurological, psychiatric, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders. 2. Any condition which places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study. 3. Use of any prescribed systemic or topical medication within 30 days of the first dose administration. 4. Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration, Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure, colon resection, irritable bowel syndrome, Crohn's disease, etc. Subjects with cholecystectomy and appendectomy may be included. 5. 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). 6. Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center. 7. History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual \[DSM\]) within 2 years before dosing, or a positive drug screen reflecting consumption of illicit drugs. 8. History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing, or a positive alcohol screen. 9. Known to have hepatitis, or known to be a carrier of the hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab), or have a positive result to the test for HBsAg, HCV Ab, or human immunodeficiency virus (HIV) antibodies at Screening. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Bioavailability (F) of Apremilast Oral Suspension Formulation | Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period. | Relative bioavailability of the oral suspension formulation compared to the tablet formulation, calculated as (AUC0-∞/Dose\[oral suspension\]) / (AUC0-∞/Dose\[tablet\]) \* 100%. |
| Lag Time (Tlag) of Apremilast | Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period. | Lag time is the delay between the time of administration and start of absorption. |
| Maximum Observed Plasma Concentration (Cmax) of Apremilast | Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period. | Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay. |
| Area Under the Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast | Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period. | Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay. AUC from time zero to the last measured time point was calculated by the linear trapezoidal method. |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) for Apremilast | Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period. | Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay. AUC from time zero to infinity was calculated as (AUC0-t + Ct/λz), where Ct is the last quantifiable concentration, and λz is the apparent terminal rate constant. |
| Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast | Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period. | Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay. |
| Terminal Elimination Half-life (T1/2) of Apremilast | Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period. | — |
| Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F) | Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period. | — |
| Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F) | Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | From first dose of study drug in treatment period 1 to 8 days after the last dose; up to 18 days. | An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be 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. A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug. A serious adverse event (SAE) is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at a single site in the United States. The study consisted of three treatment periods separated by a 5-day washout period.
Pre-assignment details
Participants were randomly assigned to one of six treatment sequences. On day 1 of each treatment sequence participants received one of the following according to their assigned treatment sequence: * Treatment A: Single oral dose of 30 mg apremilast tablet under fasted conditions * Treatment B: Single oral dose of 30 mg apremilast oral suspension formulation under fasted conditions * Treatment C: Single oral dose of 30 mg apremilast oral suspension formulation under fed conditions
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 33.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 14 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 17 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 34 | 10 / 34 | 3 / 34 | 15 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 | 0 / 34 | 0 / 34 |
Outcome results
Primary
Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: Apremilast 30 mg Tablet - Fasted | Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F) | 9.51 L/h | Geometric Coefficient of Variation 38.7 |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F) | 10.9 L/h | Geometric Coefficient of Variation 43.2 |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F) | 9.42 L/h | Geometric Coefficient of Variation 41.3 |
Primary
Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: Apremilast 30 mg Tablet - Fasted | Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F) | 108 L | Geometric Coefficient of Variation 45.2 |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F) | 133 L | Geometric Coefficient of Variation 43.7 |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F) | 102 L | Geometric Coefficient of Variation 38.9 |
Primary
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) for Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay. AUC from time zero to infinity was calculated as (AUC0-t + Ct/λz), where Ct is the last quantifiable concentration, and λz is the apparent terminal rate constant.
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Population: The pharmacokinetic population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: Apremilast 30 mg Tablet - Fasted | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) for Apremilast | 3160 ng*h/mL | Geometric Coefficient of Variation 38.7 |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) for Apremilast | 2760 ng*h/mL | Geometric Coefficient of Variation 43.2 |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) for Apremilast | 3190 ng*h/mL | Geometric Coefficient of Variation 41.3 |
Comparison: To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.90% CI: [83.2, 92.6]
Comparison: To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.90% CI: [109, 121.7]
Primary
Area Under the Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay. AUC from time zero to the last measured time point was calculated by the linear trapezoidal method.
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Population: The pharmacokinetic population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: Apremilast 30 mg Tablet - Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast | 3130 ng*h/mL | Geometric Coefficient of Variation 38.9 |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast | 2740 ng*h/mL | Geometric Coefficient of Variation 43.1 |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Area Under the Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast | 3160 ng*h/mL | Geometric Coefficient of Variation 41.3 |
Comparison: To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.90% CI: [83, 92.5]
Comparison: To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.90% CI: [109.2, 121.7]
Primary
Lag Time (Tlag) of Apremilast
Lag time is the delay between the time of administration and start of absorption.
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment A: Apremilast 30 mg Tablet - Fasted | Lag Time (Tlag) of Apremilast | 0.00 hours |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Lag Time (Tlag) of Apremilast | 0.00 hours |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Lag Time (Tlag) of Apremilast | 0.00 hours |
Primary
Maximum Observed Plasma Concentration (Cmax) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Population: The pharmacokinetic (PK) population included all participants who received at least one dose of apremilast and had at least one measurable concentration datum.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: Apremilast 30 mg Tablet - Fasted | Maximum Observed Plasma Concentration (Cmax) of Apremilast | 323 ng/mL | Geometric Coefficient of Variation 34.5 |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Maximum Observed Plasma Concentration (Cmax) of Apremilast | 274 ng/mL | Geometric Coefficient of Variation 32.2 |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Maximum Observed Plasma Concentration (Cmax) of Apremilast | 215 ng/mL | Geometric Coefficient of Variation 33.7 |
Comparison: To assess the bioavailability between the apremilast oral suspension and tablet formulation an analysis of variance (ANOVA) model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.90% CI: [77.3, 93.2]
Comparison: To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.90% CI: [71.2, 86]
Primary
Relative Bioavailability (F) of Apremilast Oral Suspension Formulation
Relative bioavailability of the oral suspension formulation compared to the tablet formulation, calculated as (AUC0-∞/Dose\[oral suspension\]) / (AUC0-∞/Dose\[tablet\]) \* 100%.
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Population: PK population. Relative bioavailability calculated for each of the oral suspension treatments as pre-specified in the Protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: Apremilast 30 mg Tablet - Fasted | Relative Bioavailability (F) of Apremilast Oral Suspension Formulation | 87.6 percent availability | Geometric Coefficient of Variation 16.1 |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Relative Bioavailability (F) of Apremilast Oral Suspension Formulation | 101 percent availability | Geometric Coefficient of Variation 14.3 |
Primary
Terminal Elimination Half-life (T1/2) of Apremilast
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: Apremilast 30 mg Tablet - Fasted | Terminal Elimination Half-life (T1/2) of Apremilast | 7.89 hours | Geometric Coefficient of Variation 34.5 |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Terminal Elimination Half-life (T1/2) of Apremilast | 8.51 hours | Geometric Coefficient of Variation 31.8 |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Terminal Elimination Half-life (T1/2) of Apremilast | 7.54 hours | Geometric Coefficient of Variation 30.8 |
Primary
Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Population: The PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment A: Apremilast 30 mg Tablet - Fasted | Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast | 2.00 hours |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast | 2.00 hours |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast | 5.00 hours |
Comparison: Tmax was analyzed by nonparametric methods. The median difference and 90% confidence interval (CI) of the median difference were calculated from the Hodges-Lehrmann estimate.p-value: 0.150890% CI: [0, 0.5]Wilcoxon signed-rank test
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: <0.000190% CI: [1.27, 3.25]Wilcoxon signed-rank test
Secondary
Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be 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. A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug. A serious adverse event (SAE) is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event.
Time frame: From first dose of study drug in treatment period 1 to 8 days after the last dose; up to 18 days.
Population: The safety population included all participants who received at least one dose of apremilast.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A: Apremilast 30 mg Tablet - Fasted | Number of Participants With Treatment-emergent Adverse Events | TEAEs leading to death | 0 Participants |
| Treatment A: Apremilast 30 mg Tablet - Fasted | Number of Participants With Treatment-emergent Adverse Events | TEAEs related to study drug | 4 Participants |
| Treatment A: Apremilast 30 mg Tablet - Fasted | Number of Participants With Treatment-emergent Adverse Events | TEAEs leading to discontinuation | 0 Participants |
| Treatment A: Apremilast 30 mg Tablet - Fasted | Number of Participants With Treatment-emergent Adverse Events | Any treatment-emergent adverse event (TEAE) | 8 Participants |
| Treatment A: Apremilast 30 mg Tablet - Fasted | Number of Participants With Treatment-emergent Adverse Events | Serious adverse events | 0 Participants |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Number of Participants With Treatment-emergent Adverse Events | TEAEs leading to death | 0 Participants |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Number of Participants With Treatment-emergent Adverse Events | Any treatment-emergent adverse event (TEAE) | 10 Participants |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Number of Participants With Treatment-emergent Adverse Events | TEAEs related to study drug | 7 Participants |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Number of Participants With Treatment-emergent Adverse Events | Serious adverse events | 0 Participants |
| Treatment B: Apremilast 30 mg Oral Suspension - Fasted | Number of Participants With Treatment-emergent Adverse Events | TEAEs leading to discontinuation | 0 Participants |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Number of Participants With Treatment-emergent Adverse Events | TEAEs related to study drug | 4 Participants |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Number of Participants With Treatment-emergent Adverse Events | TEAEs leading to death | 0 Participants |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Number of Participants With Treatment-emergent Adverse Events | Serious adverse events | 0 Participants |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Number of Participants With Treatment-emergent Adverse Events | TEAEs leading to discontinuation | 0 Participants |
| Treatment C: Apremilast 30 mg Oral Suspension - Fed | Number of Participants With Treatment-emergent Adverse Events | Any treatment-emergent adverse event (TEAE) | 6 Participants |