Healthy VolunteerPhase 1NCT01634191

Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy Adults

A Phase 1 study testing Apremilast in people with Healthy Volunteer, run by Amgen at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: Apremilast
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 2 sitesUnited States
Study dates: 1 Feb 2012to 1 Apr 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
Females must have been surgically sterilized at least 6 months prior to screening or be postmenopausal (to be confirmed by lab tests).
Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.
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
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.

Show all 10Show fewer

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.

Who cannot join

Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent form, places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
Subjects with known serum hepatitis, is a known carrier of hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody.
Subjects who have used prescription systemic or topical medications within 30 days of dosing, unless it is being used to treat a stable, chronic medical condition. This includes medication that is an inhibitor or inducer of P-glycoprotein transporter and CYP-3A4/5 used within 14 days of dosing.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Clinical Development Services
Dallas, Texas, 75247
PRA International
Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: An Open-Label, Single-Dose Study to Evaluate the Effects of Age and Sex on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Subjects

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.

Read the 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.

Conditions: Healthy Volunteer
Being tested: Apremilast
Keywords: Apremilast, pharmacokinetic, safety, Pharmacokinetics and safety in healthy volunteer subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApremilastDrug
Also called CC-10004, Otezla®
One oral 30 mg dose of apremilast

Study groups in NCT01634191
Study group	Role	What they receive
Elderly: Apremilast 30 mg	Experimental	Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. Receives: Drug: Apremilast
Younger: Apremilast 30 mg	Experimental	Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1. Receives: Drug: Apremilast

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 of Apremilast by Sex
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 outcomes (1)

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.
Measured: From first dose of study drug up to 11 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20121 Apr 2012

First posted6 Jul 2012 (estimated)
Study start1 Feb 2012
Primary completion1 Mar 2012
Study completion1 Apr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01634191
Sponsor's protocol ID: CC-10004-CP-024
Other IDs: 20200149
Status last verified: Mar 2021
First submitted: 3 Jul 2012
Last updated: 14 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose Study to Evaluate the Effects of Age and Sex on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Subjects
ClinicalTrials.gov ID: NCT01634191
Acronym / sponsor ID: CC-10004-CP-024
Conditions: Healthy Volunteer
Keywords: Apremilast, pharmacokinetic, safety, Pharmacokinetics and safety in healthy volunteer subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 1 Feb 2012 (actual)
Primary completion: 1 Mar 2012 (actual)
Study completion: 1 Apr 2012 (actual)
First posted: 6 Jul 2012 (estimated)
Results: Posted 14 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Elderly: Apremilast 30 mg	Experimental	Drug: ApremilastParticipants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
Younger: Apremilast 30 mg	Experimental	Drug: ApremilastParticipants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.
Females must have been surgically sterilized at least 6 months prior to screening or be postmenopausal (to be confirmed by lab tests).
Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.
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
Healthy male or female of any ethnic origin between the ages of 18 and 55 inclusive with a BMI between 18 and 35.

Key exclusion criteria (5 listed)

Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent form, places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
Subjects with known serum hepatitis, is a known carrier of hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody.
Subjects who have used prescription systemic or topical medications within 30 days of dosing, unless it is being used to treat a stable, chronic medical condition. This includes medication that is an inhibitor or inducer of P-glycoprotein transporter and CYP-3A4/5 used within 14 days of dosing.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ApremilastAlso: CC-10004, Otezla®One oral 30 mg dose of apremilast	Drug	Elderly: Apremilast 30 mg, Younger: Apremilast 30 mg

Primary outcome

Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) 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.
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
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.
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
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.
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
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.
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Maximum Observed Plasma Concentration (Cmax) 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.
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Maximum Observed Plasma Concentration 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.
The lower limit of quantitation for apremilast plasma concentrations was 1.0 ng/mL.
Time to Maximum Observed Plasma Concentration (Tmax) 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.
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
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.
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)
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.
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.
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.
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.
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.
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.

1 secondary outcome

Number of Participants With Adverse Events
Time frame: From first dose of study drug up to 11 days

Results and safety

Results posted to the registry on 14 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Young: Apremilast 30 mg	18	18
Elderly: Apremilast 30 mg	18	18

Primary outcome: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) 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.. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Young: Apremilast n = 18	Elderly: Apremilast n = 18
Value	2832 (28.1)	3235 (40.3)

Young: Apremilast vs Elderly: Apremilast: Geometric Mean Ratio: 113 (90% CI 94.2 to 135)

Population analysed: The pharmacokinetic (PK) population included all participants who received apremilast and had evaluable PK profiles.

Primary outcome: AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) 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.. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Males (Combined) n = 16	Females (Combined) n = 20
Value	2634 (24.5)	3382 (38.2)

Males (Combined) vs Females (Combined): Geometric Mean Ratio: 128 (90% CI 107 to 154)

Population analysed: The PK population included all participants who received apremilast and had evaluable PK profiles.

Primary outcome: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) 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.. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Young: Apremilast n = 18	Elderly: Apremilast n = 18
Value	2900 (28.7)	3323 (41.8)

Young: Apremilast vs Elderly: Apremilast: Geometric Mean Ratio: 113 (90% CI 94.1 to 135)

Population analysed: The PK population included all participants who received apremilast and had evaluable PK profiles.

Primary outcome: AUC From Time Zero Extrapolated to Infinity (AUC0-∞) 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.. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Males (Combined) n = 16	Females (Combined) n = 20
Value	2673 (24.8)	3499 (39.1)

Males (Combined) vs Females (Combined): Geometric Mean Ratio: 131 (90% CI 109 to 157)

Population analysed: The PK population included all participants who received apremilast and had evaluable PK profiles.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first dose of apremilast up to 11 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Young Males	0 of 8 (0%)	2 of 8 (25%)	Not reported
Young Females	0 of 10 (0%)	1 of 10 (10%)	Not reported
Young (Total)	0 of 18 (0%)	3 of 18 (16.7%)	Not reported
Elderly Males	0 of 8 (0%)	2 of 8 (25%)	Not reported
Elderly Females	0 of 10 (0%)	5 of 10 (50%)	Not reported
Elderly (Total)	0 of 18 (0%)	7 of 18 (38.9%)	Not reported
Overall Total	0 of 36 (0%)	10 of 36 (27.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Apremilast in people with Healthy Volunteer, run by Amgen at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) 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.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01634191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.