Trial Outcomes & Findings for Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy Adults (NCT NCT01634191)
NCT ID: NCT01634191
Last Updated: 2021-04-14
Results Overview
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing.
Results posted on
2021-04-14
Participant Flow
This study was conducted at two clinical research sites in the United States.
Participant milestones
| Measure |
Young: Apremilast 30 mg
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast 30 mg
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy Adults
Baseline characteristics by cohort
| Measure |
Young Males
n=8 Participants
Men aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Young Females
n=10 Participants
Women aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
n=8 Participants
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
n=10 Participants
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 7.48 • n=99 Participants
|
35.2 years
STANDARD_DEVIATION 7.19 • n=107 Participants
|
70.4 years
STANDARD_DEVIATION 3.62 • n=206 Participants
|
70.6 years
STANDARD_DEVIATION 4.72 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 19.23 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Body Mass Index (BMI)
|
26.6 kg/m^2
STANDARD_DEVIATION 2.43 • n=99 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 2.59 • n=107 Participants
|
26.3 kg/m^2
STANDARD_DEVIATION 2.69 • n=206 Participants
|
27.1 kg/m^2
STANDARD_DEVIATION 2.42 • n=7 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 2.47 • n=31 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Young: Apremilast
n=18 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=18 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
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
|
3235 h*ng/mL
Geometric Coefficient of Variation 40.3
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Young: Apremilast
n=16 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=20 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
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
|
3382 h*ng/mL
Geometric Coefficient of Variation 38.2
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Outcome measures
| Measure |
Young: Apremilast
n=18 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=18 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
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
|
3323 h*ng/mL
Geometric Coefficient of Variation 41.8
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Outcome measures
| Measure |
Young: Apremilast
n=16 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=20 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
AUC From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast by Sex
|
2673 h*ng/mL
Geometric Coefficient of Variation 24.8
|
3499 h*ng/mL
Geometric Coefficient of Variation 39.1
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Outcome measures
| Measure |
Young: Apremilast
n=18 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=18 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Apremilast
|
302 ng/mL
Geometric Coefficient of Variation 26.8
|
321 ng/mL
Geometric Coefficient of Variation 27.8
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Outcome measures
| Measure |
Young: Apremilast
n=16 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=20 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration of Apremilast by Sex
|
299 ng/mL
Geometric Coefficient of Variation 16.6
|
322 ng/mL
Geometric Coefficient of Variation 33.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Outcome measures
| Measure |
Young: Apremilast
n=18 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=18 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
|
2.50 hours
Interval 0.5 to 5.0
|
2.50 hours
Interval 1.0 to 5.1
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Outcome measures
| Measure |
Young: Apremilast
n=16 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=20 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast by Sex
|
2.5 hours
Interval 0.5 to 5.0
|
2.75 hours
Interval 1.0 to 5.1
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Young: Apremilast
n=18 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=18 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
Estimate of Terminal Elimination Half-life of Apremilast in Plasma (t1/2)
|
9.41 hours
Standard Deviation 2.65
|
9.15 hours
Standard Deviation 2.56
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Young: Apremilast
n=16 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=20 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
Estimate of Terminal Elimination Half-life of Apremilast in Plasma by Sex
|
8.06 hours
Standard Deviation 1.72
|
10.3 hours
Standard Deviation 2.76
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Young: Apremilast
n=18 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=18 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
Apparent Total Plasma Clearance When Dosed Orally (CL/F) of Apremilast
|
10.4 L/hr
Geometric Coefficient of Variation 28.7
|
9.03 L/hr
Geometric Coefficient of Variation 41.8
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Young: Apremilast
n=16 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=20 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
Apparent Total Plasma Clearance When Dosed Orally of Apremilast by Sex
|
11.2 L/hr
Geometric Coefficient of Variation 24.8
|
8.57 L/hr
Geometric Coefficient of Variation 39.1
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Young: Apremilast
n=18 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=18 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
Apparent Total Volume of Distribution When Dosed Orally (Vz/F) of Apremilast
|
136 liters
Geometric Coefficient of Variation 38.9
|
115 liters
Geometric Coefficient of Variation 35.3
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Young: Apremilast
n=16 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=20 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
Apparent Total Volume of Distribution When Dosed Orally (Vz/F) of Apremilast by Sex
|
128 liters
Geometric Coefficient of Variation 30.7
|
123 liters
Geometric Coefficient of Variation 43.4
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 11 daysPopulation: Participants who received apremilast
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.
Outcome measures
| Measure |
Young: Apremilast
n=8 Participants
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly: Apremilast
n=10 Participants
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
n=8 Participants
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
n=10 Participants
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events
Adverse event related to study drug
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Serious adverse events related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Discontinued due to adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Discontinued due to adverse event related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Young Males
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Young Females
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Young (Total)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Elderly Males
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Elderly Females
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Elderly (Total)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Overall Total
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Young Males
n=8 participants at risk
Men aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Young Females
n=10 participants at risk
Women aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Young (Total)
n=18 participants at risk
Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Males
n=8 participants at risk
Men aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly Females
n=10 participants at risk
Women aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Elderly (Total)
n=18 participants at risk
Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
|
Overall Total
n=36 participants at risk
All study participants received a single oral dose of 30 mg apremilast on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
0.00%
0/18 • From first dose of apremilast up to 11 days
|
12.5%
1/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
2.8%
1/36 • From first dose of apremilast up to 11 days
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
10.0%
1/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
10.0%
1/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
5.6%
2/36 • From first dose of apremilast up to 11 days
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
0.00%
0/18 • From first dose of apremilast up to 11 days
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
10.0%
1/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
2.8%
1/36 • From first dose of apremilast up to 11 days
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
10.0%
1/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
0.00%
0/18 • From first dose of apremilast up to 11 days
|
2.8%
1/36 • From first dose of apremilast up to 11 days
|
|
General disorders
PAIN
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
0.00%
0/18 • From first dose of apremilast up to 11 days
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
10.0%
1/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
2.8%
1/36 • From first dose of apremilast up to 11 days
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
0.00%
0/18 • From first dose of apremilast up to 11 days
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
20.0%
2/10 • From first dose of apremilast up to 11 days
|
11.1%
2/18 • From first dose of apremilast up to 11 days
|
5.6%
2/36 • From first dose of apremilast up to 11 days
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
0.00%
0/18 • From first dose of apremilast up to 11 days
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
10.0%
1/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
2.8%
1/36 • From first dose of apremilast up to 11 days
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
0.00%
0/18 • From first dose of apremilast up to 11 days
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
10.0%
1/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
2.8%
1/36 • From first dose of apremilast up to 11 days
|
|
Nervous system disorders
HEADACHE
|
12.5%
1/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
0.00%
0/18 • From first dose of apremilast up to 11 days
|
2.8%
1/36 • From first dose of apremilast up to 11 days
|
|
Nervous system disorders
SOMNOLENCE
|
12.5%
1/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
0.00%
0/18 • From first dose of apremilast up to 11 days
|
2.8%
1/36 • From first dose of apremilast up to 11 days
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
0.00%
0/18 • From first dose of apremilast up to 11 days
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
10.0%
1/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
2.8%
1/36 • From first dose of apremilast up to 11 days
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
0.00%
0/18 • From first dose of apremilast up to 11 days
|
12.5%
1/8 • From first dose of apremilast up to 11 days
|
0.00%
0/10 • From first dose of apremilast up to 11 days
|
5.6%
1/18 • From first dose of apremilast up to 11 days
|
2.8%
1/36 • From first dose of apremilast up to 11 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER