Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

A Phase 1 study testing Apremilast in people with Pharmacokinetics, run by Amgen at 1 site in South Korea.

Completed

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

Trial summary

This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple doses of apremilast in healthy adult Korean males. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: Apremilast
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteSouth Korea
Study dates: 22 Jun 2016to 5 Aug 2016
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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Subjects must satisfy the following criteria to be enrolled in the study:
Healthy adult male Korean subjects between 18 and 45 years of age (inclusive) at the time of signing the informed consent form (ICF).
Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Must be able to communicate with the Investigator and understand and comply with the requirements of the study.
Must be in good health as determined by the Investigator according to past medical history, physical examination (PE), vital signs, 12-lead electrocardiogram (ECG), and laboratory tests.

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Must have a body mass index (BMI) between 18 and 30 kg/m^2 (inclusive).
Clinical laboratory tests must be within normal limits or considered by the Investigator to be not clinically significant.
Vital signs (systolic and diastolic blood pressure, pulse rate, and oral [or tympanic] body temperature) will be assessed in the supine position after the subject has rested for at least five minutes. Subject must be afebrile (febrile [oral or tympanic] is defined as ≥ 38°C or 100.3°F) with vital signs within the following ranges:
Systolic blood pressure: 90 to 140 mm Hg;
Diastolic blood pressure: 50 to 90 mm Hg;
Pulse rate: 40 to 110 bpm.
Must have a normal or clinically acceptable 12-lead ECG. Subjects must have a QTc value ≤ 450 msec.
Must have a normal or clinically acceptable physical examination.
Contraception Requirements:
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 investigational product (IP).
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 IP.

Who cannot join

The presence of any of the following will exclude any healthy subject from enrollment into the study:
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.
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.
Use of any prescribed systemic or topical medication within 30 days of the first dose administration.
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.

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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).
Donated blood or plasma within eight weeks before the first dose administration to a blood bank or blood donation center.
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.
History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing, or a positive alcohol screen.
Known to have hepatitis, or known to be a carrier of the hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies, or have a positive result to the test for HBsAg, HCV antibodies or human immunodeficiency virus (HIV) antibodies at Screening.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 03080

Other trials in South Korea

About this study

Official title: A Phase 1, Open-label, Two Part Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple doses of apremilast in healthy adult Korean males.

Read the detailed description

The study will consist of two parts. Part 1 will evaluate the PK of ascending single doses of apremilast. Part 2 will evaluate the PK of apremilast when administered as multiple doses over 14 days.

Conditions: Pharmacokinetics
Being tested: Apremilast, Placebo
Keywords: Pharmacokinetics, Apremilast, Healthy Adult Male, Korean 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®
Tablet for oral administration
PlaceboDrug
Tablet for oral administration

Study groups in NCT02802735
Study group	Role	What they receive
Part 1: Apremilast 20 mg	Experimental	A single oral dose of 20 mg apremilast. Receives: Drug: Apremilast
Part 1: Apremilast 30 mg	Experimental	A single oral dose of 30 mg apremilast. Receives: Drug: Apremilast
Part 1: Apremilast 40 mg	Experimental	A single oral dose of 40 mg apremilast. Receives: Drug: Apremilast
Part 2: Apremilast 30 mg BID	Experimental	30 mg apremilast orally twice a day (BID) for 14 days. Receives: Drug: Apremilast
Part 2: Placebo	Placebo comparator	Matching placebo orally twice a day for 14 days. Receives: Drug: Placebo

What is being measured

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

Part 1: Maximum Observed Plasma Concentration (Cmax) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Measured: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
Measured: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast
Measured: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for Apremilast
Measured: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 1: Terminal Elimination Half-life (T1/2) for Apremilast
Measured: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 1: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)
Measured: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 1: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)
Measured: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 2: Area Under the Plasma Concentration-time Curve During a Dosage Interval (AUCτ) for Apremilast
Area under the plasma concentration-time curve during a dosage interval (tau) at steady state, where tau is 12 hours.
Measured: Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose
Part 2: Maximum Observed Plasma Concentration (Cmax) of Apremilast
Measured: Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose
Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
Measured: Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose
Part 2: Terminal Elimination Half-life (T1/2) for Apremilast
Measured: Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose
Part 2: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)
Measured: Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose
Part 2: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)
Measured: Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose
Part 2: Ratio of Accumulation
Ratio of accumulation calculated as Day 14 AUC0-τ / Day 1 AUC0-τ
Measured: Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose, and on day 14 only at 24, 36, 48, 60, and 72 hours after the morning dose

Secondary outcomes (1)

Number of Participants With Treatment-emergent Adverse Events (AEs)
Measured: Part 1, up to 40 days; Part 2, up to 24 days

Timeline

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

22 Jun 20165 Aug 2016

First posted16 Jun 2016 (estimated)
Study start22 Jun 2016
Primary completion5 Aug 2016
Study completion5 Aug 2016

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 PharmacokineticsStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Part 1 of the study was a 3-treatment period, 3-sequence crossover study. Part 2 was a parallel-group, placebo-controlled, single-period study.
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02802735
Sponsor's protocol ID: CC-10004-CP-033
Status last verified: Jun 2021
First submitted: 14 Jun 2016
Last updated: 6 Jul 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 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Two Part Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects
ClinicalTrials.gov ID: NCT02802735
Acronym / sponsor ID: CC-10004-CP-033
Conditions: Pharmacokinetics
Keywords: Pharmacokinetics, Apremilast, Healthy Adult Male, Korean Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 22 Jun 2016 (actual)
Primary completion: 5 Aug 2016 (actual)
Study completion: 5 Aug 2016 (actual)
First posted: 16 Jun 2016 (estimated)
Results: Posted 6 Jul 2021

Clinical summary

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

This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple doses of apremilast in healthy adult Korean males.

Detailed description

The study will consist of two parts. Part 1 will evaluate the PK of ascending single doses of apremilast. Part 2 will evaluate the PK of apremilast when administered as multiple doses over 14 days.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5
Model description: Part 1 of the study was a 3-treatment period, 3-sequence crossover study. Part 2 was a parallel-group, placebo-controlled, single-period study.

Arm	Type	Receives
Part 1: Apremilast 20 mg	Experimental	Drug: ApremilastA single oral dose of 20 mg apremilast.
Part 1: Apremilast 30 mg	Experimental	Drug: ApremilastA single oral dose of 30 mg apremilast.
Part 1: Apremilast 40 mg	Experimental	Drug: ApremilastA single oral dose of 40 mg apremilast.
Part 2: Apremilast 30 mg BID	Experimental	Drug: Apremilast30 mg apremilast orally twice a day (BID) for 14 days.
Part 2: Placebo	Placebo comparator	Drug: PlaceboMatching placebo orally twice a day for 14 days.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (17 listed)

Subjects must satisfy the following criteria to be enrolled in the study:
Healthy adult male Korean subjects between 18 and 45 years of age (inclusive) at the time of signing the informed consent form (ICF).
Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Must be able to communicate with the Investigator and understand and comply with the requirements of the study.

Key exclusion criteria (11 listed)

The presence of any of the following will exclude any healthy subject from enrollment into the study:

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®Tablet for oral administration	Drug	Part 1: Apremilast 20 mg, Part 1: Apremilast 30 mg, Part 1: Apremilast 40 mg, Part 2: Apremilast 30 mg BID
PlaceboTablet for oral administration	Drug	Part 2: Placebo

Primary outcome

Part 1: Maximum Observed Plasma Concentration (Cmax) of Apremilast
Time frame: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
Time frame: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast
Time frame: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for Apremilast
Time frame: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 1: Terminal Elimination Half-life (T1/2) for Apremilast
Time frame: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 1: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)
Time frame: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 1: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)
Time frame: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.
Part 2: Area Under the Plasma Concentration-time Curve During a Dosage Interval (AUCτ) for Apremilast
Time frame: Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose
Area under the plasma concentration-time curve during a dosage interval (tau) at steady state, where tau is 12 hours.
Part 2: Maximum Observed Plasma Concentration (Cmax) of Apremilast
Time frame: Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose
Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
Time frame: Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose
Part 2: Terminal Elimination Half-life (T1/2) for Apremilast
Time frame: Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose
Part 2: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)
Time frame: Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose
Part 2: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)
Time frame: Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose
Part 2: Ratio of Accumulation
Time frame: Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose, and on day 14 only at 24, 36, 48, 60, and 72 hours after the morning dose
Ratio of accumulation calculated as Day 14 AUC0-τ / Day 1 AUC0-τ

1 secondary outcome

Number of Participants With Treatment-emergent Adverse Events (AEs)
Time frame: Part 1, up to 40 days; Part 2, up to 24 days

Results and safety

Results posted to the registry on 6 Jul 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
Part 1: Apremilast 20 mg / 30 mg / 40 mg	4	4
Part 1: Apremilast 30 mg / 20 mg / 40 mg	4	3
Part 1: Apremilast 40 mg / 20 mg / 30 mg	4	4
Part 2: Apremilast 30 mg BID	12	12
Part 2: Placebo BID	4	4

Primary outcome: Part 1: Maximum Observed Plasma Concentration (Cmax) of Apremilast

Time frame: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Part 1: Apremilast 20 mg n = 11	Part 1: Apremilast 30 mg n = 12	Part 1: Apremilast 40 mg n = 12
Value	205 (32.1)	273 (32.1)	373 (19.7)

Population analysed: Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.

Primary outcome: Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast

Time frame: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.. Median (Full Range). Unit: hours

Measure	Part 1: Apremilast 20 mg n = 11	Part 1: Apremilast 30 mg n = 12	Part 1: Apremilast 40 mg n = 12
Value	3.0 (1.5 to 5.0)	3.0 (1.5 to 5.0)	2.0 (0.5 to 5.0)

Population analysed: Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.

Primary outcome: Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast

Measure	Part 1: Apremilast 20 mg n = 11	Part 1: Apremilast 30 mg n = 12	Part 1: Apremilast 40 mg n = 12
Value	1770 (25.8)	2330 (22.6)	3470 (25.7)

Population analysed: Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.

Primary outcome: Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for Apremilast

Measure	Part 1: Apremilast 20 mg n = 11	Part 1: Apremilast 30 mg n = 12	Part 1: Apremilast 40 mg n = 12
Value	1790 (25.5)	2360 (22.1)	3500 (25.6)

Population analysed: Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Part 1, up to 40 days; Part 2, up to 24 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Apremilast 20 mg	0 of 11 (0%)	2 of 11 (18.2%)	Not reported
Part 1: Apremilast 30 mg	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
Part 1: Apremilast 40 mg	0 of 12 (0%)	3 of 12 (25%)	Not reported
Part 1: Total	0 of 12 (0%)	4 of 12 (33.3%)	Not reported
Part 2: Apremilast 30 mg BID	0 of 12 (0%)	7 of 12 (58.3%)	Not reported
Part 2: Placebo BID	0 of 4 (0%)	3 of 4 (75%)	Not reported
Part 2: Total	0 of 16 (0%)	10 of 16 (62.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Expanded Access for CC-10004Link 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

1 site 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 Pharmacokinetics, run by Amgen at 1 site in South Korea.

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 17 inclusion and 11 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 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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. Some participants in this study may receive a placebo. 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 6 Jul 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?

Part 1: Maximum Observed Plasma Concentration (Cmax) of Apremilast (time frame: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.). 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 NCT02802735.

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 6 Jul 2021.