Healthy VolunteersPhase 1NCT04139226
A Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of a New Spray Dried Dispersion (SDD) Formulation of CC-11050 After Single Dose of CC-11050 and to Evaluate the Pharmacokinetics of CC-11050 Under Fasted and Fed Conditions and After Coadministration With Omeprazole
A Phase 1 study testing CC-11050 in people with Healthy Volunteers, run by Amgen at 1 site in United States.
Trial summary
This is a two-part study to be conducted at single study center, (additional center(s) may be selected if needed) to assess the safety, tolerability, PK and PD parameters for a new SDD formulation of CC-11050 in healthy subjects. The effects of a high-fat meal and omeprazole will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CC-11050
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2019to 27 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject is a male, or a non-pregnant and non-nursing female between 18 and 55 years, inclusive, of age 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.
- Subject has a BMI ≥ 18 and ≤ 33 kg/m2 at screening.
- Female subject
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- Must have a negative pregnancy test
- If postmenopausal: must have follicular stimulating hormone (FSH) test result >40 IU/L and a negative pregnancy test
- Contraception Requirements:
- Must comply with the following acceptable forms of contraception. All females of childbearing potential (FCBP) must use one of the approved contraceptive2 options described below while taking CC-11050 and for at least 28 days after administration of the CC-11050 dose. At the time of study entry, and at any time during the study when a FCFP's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy. A FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: One highly effective method (eg, hormonal contraception [oral, injection, implant, transdermal patch, vaginal ring]; intrauterine device; tubal ligation; or partner's vasectomy) and 1 additional form (latex condom or any nonlatex condom not made of natural [animal] membrane [eg, polyurethane], diaphragm, sponge).
- OR Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane) PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
- A male subject must:
- Practice true abstinence3 (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural [animal] membrane [latex condoms are recommended]) during sexual contact with a pregnant female or female of FCBP while participating in the study, during dose interruptions, and for at least 28 days after the dose of IP, even if he has undergone a successful vasectomy.
- Subject has clinical laboratory safety test results that are within normal limits (WNL) or acceptable to the Investigator.
- Subject is afebrile (febrile is defined as ≥ 38°C or ≥100.4°F), with supine systolic blood pressure ≥ 90 and ≤ 150 mm Hg, supine diastolic blood pressure ≥ 50 and ≤ 90 mm Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute at screening
- Subject is in good health as determined by past medical history, PE, vital signs, 12-lead ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (ie, hematology, chemistry, and urinalysis) and 12-lead ECGs must be WNL or clinically acceptable as judged by the Investigator.
- Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition:
- If male, the subject has a QTcF value ≤ 450 msec at screening
- If female, the subject has a QTcF value ≤ 470 msec at screening
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject is pregnant or breastfeeding.
- Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever was longer).
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- Subject has used moderate or strong CYP3A4/5 inducers and/or inhibitors (including St. John's wort) within 30 days prior to dosing. The Indiana University P450 Drug Interactions Flockhart Table™ may be consulted for a list of such medications.
- Subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure. A subject with an appendectomy and/or cholecystectomy may be included.
- Subject has donated blood or plasma within 8 weeks before dose administration to a blood bank or blood donation center.
- Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dose administration, or positive drug screening test reflecting consumption of illicit drugs unless positive drug screen is due to prescription drug use that is approved by the Investigator and the Medical Monitor.
- Subject has a history of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 1 year before dose administration, or a positive alcohol screen.
- Subjects smokes more than 10 cigarettes per day, or the equivalent in order tobacco products (self-reported).
- Subject has had a positive result to the test for human immunodeficiency virus (HIV) antibodies at Screening.
- Chronic or resolved Hepatitis B or Hepatitis C are acceptable only if sequelae are limited to hepatic involvement and its consequent comorbidities. (ie, vasculitis, clinically significant globulinemia, etc. are unacceptable).
- Subject has received a live vaccination (excluding seasonal flu vaccination) within 30 days of dosing.
- Used prescribed systemic or topic medication within 30 days of the first dose administration
- Used any non-prescribed systemic or topic medication (including vitamin/mineral supplements, and herbal medicines, eg, St. John's Wort) within 14 days of the first dose administration, unless Sponsor agreement is obtained.
- History of significant multiple and/or severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or.
- Subject is, for any reason, deemed by the Investigator to be inappropriate for this study, including a subject who is unable to communicate or to cooperate with the investigator or the clinical staff.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CC-11050 After Single and Multiple Doses of CC-11050 and Evaluate CC-11050 Pharmacokinetics Under Fasted and Fed Conditions and After Administration of CC-11050 Alone Compared to Co-administration With a Proton Pump Inhibitor in Healthy Adult Subjects
This is a two-part study to be conducted at single study center, (additional center(s) may be selected if needed) to assess the safety, tolerability, PK and PD parameters for a new SDD formulation of CC-11050 in healthy subjects. The effects of a high-fat meal and omeprazole will also be assessed. Blood samples will be collected at prespecified times for PK, clinical laboratory safety assessments, PD (Part 1 only), and/or exploratory analyses. Safety will be monitored throughout the study from the time the ICF is signed through study completion.
- Conditions
- Healthy Volunteers
- Being tested
- CC-11050
- Keywords
- CC-11050, Safety, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-11050Drug
CC-11050
| Study group | Role | What they receive |
|---|---|---|
| Administration of CC-11050 | Experimental | Part 1: Single Ascending Dose Part 2: drug-drug interaction/ food effect (DDI/FE) Receives: Drug: CC-11050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values (as specified by the criteria in Section 10.3), regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Measured: From enrollment until at least 28 days after completion of study treatment
Secondary outcomes (10)
Pharmacokinetics - Cmax
Maximum plasma concentration of drug
Measured: Up to approximately 8 days at hour 192
Pharmacokinetics - Tmax
Time to reach maximum observed plasma concentration
Measured: Up to approximately 8 days at hour 192
Pharmacokinetics - AUC 0-∞
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Measured: Up to approximately 8 days at hour 192
Pharmacokinetics - AUC 0-t
Area under the plasma concentration-time curve from time zero to the last measured time point
Measured: Up to approximately 8 days at hour 192
Pharmacokinetics - AUC 0-24
Area under the plasma concentration-time curve from time zero to 24 hours
Measured: Up to approximately 8 days at hour 192
Pharmacokinetics - AUC 0-12
Area under the plasma concentration-time curve from time zero to 12 hours
Measured: Up to approximately 8 days at hour 192
Pharmacokinetics - t1/2
Terminal elimination half-life
Measured: Up to approximately 8 days at hour 192
Pharmacokinetics - Accumulation index (Rac)
Accumulation ratio
Measured: Up to approximately 8 days at hour 192
Pharmacokinetics - CL/F
Apparent total plasma clearance when dosed orally
Measured: Up to approximately 8 days at hour 192
Pharmacokinetics - Vz/F
Apparent volume of distribution when dosed orally
Measured: Up to approximately 8 days at hour 192
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start28 Aug 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139226
- Sponsor's protocol ID
- CC-11050-CP-010
- Other IDs
- U1111-1240-5519
- Status last verified
- Jun 2020
- First submitted
- 23 Oct 2019
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CC-11050 After Single and Multiple Doses of CC-11050 and Evaluate CC-11050 Pharmacokinetics Under Fasted and Fed Conditions and After Administration of CC-11050 Alone Compared to Co-administration With a Proton Pump Inhibitor in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04139226
- Acronym / sponsor ID
- CC-11050-CP-010
- Conditions
- Healthy Volunteers
- Keywords
- CC-11050, Safety, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-part study to be conducted at single study center, (additional center(s) may be selected if needed) to assess the safety, tolerability, PK and PD parameters for a new SDD formulation of CC-11050 in healthy subjects. The effects of a high-fat meal and omeprazole will also be assessed. Blood samples will be collected at prespecified times for PK, clinical laboratory safety assessments, PD (Part 1 only), and/or exploratory analyses. Safety will be monitored throughout the study from the time the ICF is signed through study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of CC-11050 | Experimental | Drug: CC-11050Part 1: Single Ascending Dose Part 2: drug-drug interaction/ food effect (DDI/FE) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Subject is a male, or a non-pregnant and non-nursing female between 18 and 55 years, inclusive, of age 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.
- Subject has a BMI ≥ 18 and ≤ 33 kg/m2 at screening.
- Female subject
Key exclusion criteria (19 listed)
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject is pregnant or breastfeeding.
- Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever was longer).
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 |
|---|---|---|
| CC-11050CC-11050 | Drug | Administration of CC-11050 |
Primary outcome
Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of study treatment
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values (as specified by the criteria in Section 10.3), regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
10 secondary outcomes
Pharmacokinetics - Cmax
Time frame: Up to approximately 8 days at hour 192
Pharmacokinetics - Tmax
Time frame: Up to approximately 8 days at hour 192
Pharmacokinetics - AUC 0-∞
Time frame: Up to approximately 8 days at hour 192
Pharmacokinetics - AUC 0-t
Time frame: Up to approximately 8 days at hour 192
Pharmacokinetics - AUC 0-24
Time frame: Up to approximately 8 days at hour 192
Pharmacokinetics - AUC 0-12
Time frame: Up to approximately 8 days at hour 192
Pharmacokinetics - t1/2
Time frame: Up to approximately 8 days at hour 192
Pharmacokinetics - Accumulation index (Rac)
Time frame: Up to approximately 8 days at hour 192
Pharmacokinetics - CL/F
Time frame: Up to approximately 8 days at hour 192
Pharmacokinetics - Vz/F
Time frame: Up to approximately 8 days at hour 192
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
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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 CC-11050 in people with Healthy Volunteers, run by Amgen at 1 site 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 19 inclusion and 19 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 22 Jun 2020. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events (AEs) (time frame: From enrollment until at least 28 days after completion of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2020; AzTrials last refreshed its copy on 6 Nov 2026.