CompletedNCT02802735Updated Jul 6, 2021Results posted

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

A Phase 1 interventional study of Apremilast and Placebo in Pharmacokinetics, sponsored by Amgen. Completed at 1 site in Korea, Republic of. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-06.

Sponsored by Amgen · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 28
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Male

Study 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 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 studied

Pharmacokinetics

Keywords

Pharmacokinetics
Apremilast
Healthy Adult Male
Korean Subjects

In context

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

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.
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.

Exclusion criteria

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.
5. 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.
6. 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).
7. Donated blood or plasma within eight weeks before the first dose administration to a blood bank or blood donation center.
8. 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.
9. History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing, or a positive alcohol screen.
10. 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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 28 participants (actual)

Study arms

Experimental
Part 1: Apremilast 20 mg
A single oral dose of 20 mg apremilast.
Drug: Apremilast
Experimental
Part 1: Apremilast 30 mg
A single oral dose of 30 mg apremilast.
Drug: Apremilast
Experimental
Part 1: Apremilast 40 mg
A single oral dose of 40 mg apremilast.
Drug: Apremilast
Experimental
Part 2: Apremilast 30 mg BID
30 mg apremilast orally twice a day (BID) for 14 days.
Drug: Apremilast
Placebo comparator
Part 2: Placebo
Matching placebo orally twice a day for 14 days.
Drug: Placebo

Interventions

DrugApremilast
Tablet for oral administration
Also known as: CC-10004, OTEZLA®
DrugPlacebo
Tablet for oral administration

What researchers measure

Primary outcomes

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.
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: 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
Area under the plasma concentration-time curve during a dosage interval (tau) at steady state, where tau is 12 hours.
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: 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
Ratio of accumulation calculated as Day 14 AUC0-τ / Day 1 AUC0-τ
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

Secondary outcomes

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

Results

Posted Jul 6, 2021

Participant flow

This was a two-part study in healthy Korean men. The study was conducted at 1 clinic in Korea.

Participant flow — Overall Study
Milestone	Part 1: Apremilast 20 mg / 30 mg / 40 mg	Part 1: Apremilast 30 mg / 20 mg / 40 mg	Part 1: Apremilast 40 mg / 20 mg / 30 mg	Part 2: Apremilast 30 mg BID	Part 2: Placebo BID
Started	4	4	4	12	4
Completed	4	3	4	12	4
Not completed	0	1	0	0	0
Withdrew: Withdrawal by subject	0	1	0	0	0

Outcome measures

PrimaryPart 1: 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:: 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.
Reported as:: Geometric mean · ng/mL

Part 1: Maximum Observed Plasma Concentration (Cmax) of Apremilast
ng/mL	Part 1: Apremilast 20 mg	Part 1: Apremilast 30 mg	Part 1: Apremilast 40 mg
Part 1: Maximum Observed Plasma Concentration (Cmax) of Apremilast	205 ± 32.1	273 ± 32.1	373 ± 19.7

PrimaryPart 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.
Reported as:: Median · hours

Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
hours	Part 1: Apremilast 20 mg	Part 1: Apremilast 30 mg	Part 1: Apremilast 40 mg
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast	3.0 (1.5 to 5.0)	3.0 (1.5 to 5.0)	2.0 (0.5 to 5.0)

PrimaryPart 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.
Reported as:: Geometric mean · ng*hr/mL

Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast
ng*hr/mL	Part 1: Apremilast 20 mg	Part 1: Apremilast 30 mg	Part 1: Apremilast 40 mg
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast	1770 ± 25.8	2330 ± 22.6	3470 ± 25.7

PrimaryPart 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.
Reported as:: Geometric mean · ng*hr/mL

Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for Apremilast
ng*hr/mL	Part 1: Apremilast 20 mg	Part 1: Apremilast 30 mg	Part 1: Apremilast 40 mg
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for Apremilast	1790 ± 25.5	2360 ± 22.1	3500 ± 25.6

PrimaryPart 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.
Reported as:: Geometric mean · hours

Part 1: Terminal Elimination Half-life (T1/2) for Apremilast
hours	Part 1: Apremilast 20 mg	Part 1: Apremilast 30 mg	Part 1: Apremilast 40 mg
Part 1: Terminal Elimination Half-life (T1/2) for Apremilast	7.4 ± 35.2	8.2 ± 44.4	7.4 ± 36.8

PrimaryPart 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.
Reported as:: Geometric mean · liters/hour

Part 1: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)
liters/hour	Part 1: Apremilast 20 mg	Part 1: Apremilast 30 mg	Part 1: Apremilast 40 mg
Part 1: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)	11.1 ± 25.5	12.7 ± 22.1	11.4 ± 25.6

PrimaryPart 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.
Reported as:: Geometric mean · liters

Part 1: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)
liters	Part 1: Apremilast 20 mg	Part 1: Apremilast 30 mg	Part 1: Apremilast 40 mg
Part 1: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)	120 ± 47.6	151 ± 49.6	122 ± 38.7

PrimaryPart 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.

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
Reported as:: Geometric mean · ng*hr/mL

Part 2: Area Under the Plasma Concentration-time Curve During a Dosage Interval (AUCτ) for Apremilast
ng*hr/mL	Part 2: Apremilast 30 mg BID
Day 1	1610 ± 33.0
Day 14	2600 ± 34.3

PrimaryPart 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
Reported as:: Geometric mean · ng/mL

Part 2: Maximum Observed Plasma Concentration (Cmax) of Apremilast
ng/mL	Part 2: Apremilast 30 mg BID
Day 1	283 ± 34.3
Day 14	408 ± 36.5

PrimaryPart 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
Reported as:: Median · hours

Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
hours	Part 2: Apremilast 30 mg BID
Day 1	2.00 (1.00 to 5.00)
Day 14	1.50 (1.00 to 3.00)

PrimaryPart 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
Reported as:: Geometric mean · hours

Part 2: Terminal Elimination Half-life (T1/2) for Apremilast
hours	Part 2: Apremilast 30 mg BID
Part 2: Terminal Elimination Half-life (T1/2) for Apremilast	7.80 ± 31.4

PrimaryPart 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
Reported as:: Geometric mean · liters/hour

Part 2: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)
liters/hour	Part 2: Apremilast 30 mg BID
Part 2: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)	11.5 ± 34.3

PrimaryPart 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
Reported as:: Geometric mean · liters

Part 2: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)
liters	Part 2: Apremilast 30 mg BID
Part 2: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)	130 ± 53.3

PrimaryPart 2: Ratio of Accumulation

Ratio of accumulation calculated as Day 14 AUC0-τ / Day 1 AUC0-τ

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
Reported as:: Geometric mean · ratio

Part 2: Ratio of Accumulation
ratio	Part 2: Apremilast 30 mg BID
Part 2: Ratio of Accumulation	1.62 ± 36.0

SecondaryNumber of Participants With Treatment-emergent Adverse Events (AEs)

Time frame:: Part 1, up to 40 days; Part 2, up to 24 days
Reported as:: Count of participants · Participants

Number of Participants With Treatment-emergent Adverse Events (AEs)
Participants	Part 1: Apremilast 20 mg	Part 1: Apremilast 30 mg	Part 1: Apremilast 40 mg	Part 2: Apremilast 30 mg BID	Part 2: Placebo BID
Any treatment-emergent adverse event (TEAE)	2	1	3	7	3
TEAE related to study drug	1	1	2	6	2
Serious adverse events	0	0	0	0	0
Serious adverse events related o study dug	0	0	0	0	0
TEAE leading to discontinuation	0	0	0	0	0
Treatment-related TEAE leading to discontinuation	0	0	0	0	0
Deaths	0	0	0	0	0

Adverse events

Collected over Part 1, up to 40 days; Part 2, up to 24 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1: Apremilast 20 mg	—	0/11 (0%)	2/11 (18.2%)
Part 1: Apremilast 30 mg	—	0/12 (0%)	1/12 (8.3%)
Part 1: Apremilast 40 mg	—	0/12 (0%)	3/12 (25%)
Part 1: Total	—	0/12 (0%)	4/12 (33.3%)
Part 2: Apremilast 30 mg BID	—	0/12 (0%)	7/12 (58.3%)
Part 2: Placebo BID	—	0/4 (0%)	3/4 (75%)
Part 2: Total	—	0/16 (0%)	10/16 (62.5%)

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	Part 1: Apremilast 20 mg	Part 1: Apremilast 30 mg	Part 1: Apremilast 40 mg	Part 1: Total	Part 2: Apremilast 30 mg BID	Part 2: Placebo BID	Part 2: Total
HeadacheNervous system disorders	0/11	0/12	0/12	0/12	4/12	1/4	5/16
Upper respiratory tract infectionInfections and infestations	0/11	0/12	0/12	0/12	3/12	1/4	4/16
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	0/11	0/12	0/12	0/12	1/12	1/4	2/16
RashSkin and subcutaneous tissue disorders	0/11	0/12	0/12	0/12	1/12	1/4	2/16
DiarrhoeaGastrointestinal disorders	1/11	1/12	1/12	1/12	2/12	0/4	2/16
NauseaGastrointestinal disorders	0/11	0/12	2/12	2/12	0/12	0/4	0/16
EpistaxisRespiratory, thoracic and mediastinal disorders	1/11	0/12	0/12	1/12	0/12	0/4	0/16
Skin exfoliationSkin and subcutaneous tissue disorders	1/11	1/12	0/12	1/12	1/12	0/4	1/16
Abdominal pain upperGastrointestinal disorders	0/11	0/12	0/12	0/12	1/12	0/4	1/16
Skin abrasionInjury, poisoning and procedural complications	0/11	0/12	0/12	0/12	1/12	0/4	1/16

Baseline characteristics

All enrolled participants

Age, Continuous
Age, Continuous(years)	Part 1: Apremilast	Part 2: Apremilast 30 mg BID	Part 2: Placebo BID	Total
Mean	29.8 (19.0 to 43.0)	30.8 (24.0 to 41.0)	25.5 (20.0 to 31.0)	29.6 (19.0 to 43.0)

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1: Apremilast	Part 2: Apremilast 30 mg BID	Part 2: Placebo BID	Total
Female	0	0	0	0
Male	12	12	4	28

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Part 1: Apremilast	Part 2: Apremilast 30 mg BID	Part 2: Placebo BID	Total
Asian	12	12	4	28

Study locations

1 site

Seoul National University Hospital
Seoul, 03080, Korea, Republic of

References and documents

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting information: Study protocol, Sap, Icf, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02802735
Lead sponsor: Amgen
Responsible party: Sponsor
First posted: Jun 16, 2016
Start date: Jun 22, 2016
Primary completion: Aug 5, 2016
Completion: Aug 5, 2016
Results posted: Jul 6, 2021
Last update: Jul 6, 2021

Study contacts

study director · Amgen

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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