Healthy VolunteerPhase 1NCT04297124
A Study to Evaluate the Metabolism and Excretion of [14C]-CC-90009 in Healthy Male Subjects
A Phase 1 study testing CC-90009 and [14C] in people with Healthy Volunteer, run by Celgene at 1 site in United States.
Trial summary
CC-90009-CP-001 is a Phase 1, single-center, open-label, clinical pharmacology study to measure how much CC 90009 gets into the bloodstream, how much is eliminated in urine and stool, and how long it takes the body to get rid of it. In addition, the safety and tolerability of CC 90009 will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- CC-90009 and [14C]
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 4 Jun 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
- Subject is male.
- 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 is in good health, as determined by the Investigator based on a physical examination at screening.
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- Subject agrees to abide by the requirements and restrictions outlined in the CC-90009 Pregnancy Prevention Plan for Subjects in Clinical Trials.
- All subjects must avoid donating semen or sperm and practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg calendar, ovulation, symptothermal or post ovulation methods] and withdrawal are not acceptable methods of contraception.) or condom use during sexual contact with a pregnant female or a female of childbearing potential (FCBP) while receiving CC-90009 and for at least 28 days after the dose, even if he has undergone a successful vasectomy. If engaging in sexual contact, inform their partners who are FCBP to use two methods of reliable contraception, one highly effective and one additional effective, throughout the entire duration of CC-90009 and for at least 28 days after their dose of CC-90009. Partners of male subjects who are females of childbearing potential must use contraception during the same duration as the male subject to avoid pregnancy. If a pregnancy occurs with your partner, notify the doctor conducting the study immediately. The following are examples of highly effective and additional effective methods of contraception:
- Examples of highly effective methods:
- Intrauterine device (IUD)
- Hormonal (birth control pills, injections, implants, levonorgestrel-releasing intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g. desogestrel])
- Tubal ligation
- Partner's vasectomy
- Examples of additional effective methods:
- Male condom
- Diaphragm
- Cervical Cap
- Subject has a body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
- Protocol-specified clinical laboratory safety test results should be within the reference range of the clinical laboratory being used by the study site at screening and at baseline (Day -1).
- Subject is afebrile, with supine systolic blood pressure (BP) ≥ 100 and ≤ 140 mmHg, supine diastolic BP ≥ 50 and ≤ 90 mmHg, and resting pulse rate ≥ 40 and ≤ 110 bpm at screening and Day -1.
- Subject has a normal or clinically acceptable 12-lead electrocardiogram (ECG), with a QTcF value ≤ 430 msec, at screening and Day -1.
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 or other study participants at unacceptable risk if he were to participate in the study.
- Subject has a past or current history of any condition affecting calcium homeostasis including, but not limited to: hypocalcemia, parathyroid disorders, vitamin D level lower than 20 ng/mL, disorders of phosphate or magnesium metabolism. The Investigator should contact the Sponsor for questions on any disorders that may be related to calcium homeostasis. Subjects with vitamin D levels < 30 ng/mL are not permitted to serve as sentinel subjects or alternates for the sentinel subjects.
- Subject has a history of prior infusion reactions, anaphylactic reactions, or anaphylactoid reactions to any medication regardless of severity.
- Subject participated in a radiolabeled drug study, where exposures either are known or unknown to the Investigator, within the previous 12 months prior to Day -1. The total 12-month exposure from this study and a maximum of 2 other previous studies within 4 to 12 months of this study will be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1: less than 5,000 mrem whole body annual exposure, with consideration given to the half-lives of the previous radiolabeled study drugs received.
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- Subject was exposed to significant radiation (eg, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Day -1. All questions regarding this criterion should be discussed with the Sponsor.
- History of less than 1 to 2 bowel movements per day.
- Subject is unable to take calcium citrate, vitamin D3, Dulcolax®, acetaminophen or diphenhydramine because of allergy or other intolerance.
- Subject has any condition that confounds the ability to interpret data from the study. The Investigator should contact the Sponsor for questions about eligibility based on this criterion.
- Subject was exposed to an investigational drug (new chemical entity) within 30 days prior to dosing, or 5 half-lives of that investigational drug, if known (whichever is longer).
- Subject has used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 14 days or 5 half-lives of that medication, whichever is longer, prior to dosing.
- Subject has used any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines) within 7 days prior to dosing.
- Subject has used cytochrome P (CYP) 450 inducers and/or inhibitors (including St. John's Wort) within 30 days prior to dosing. The Indiana University "Cytochrome P450 Drug Interaction Table" should be utilized to determine inducers and/or inhibitors of CYP (http://medicine.iupui.edu/clinpharm/ddis/table.aspx).
- Subject has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure. Note: prior appendectomy is acceptable, but prior cholecystectomy would result in exclusion from the study.
- Subject donated blood or plasma within 8 weeks prior to dosing 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 [DSM]) within 2 years prior to dosing, or positive drug test reflecting consumption of illicit drugs.
- Subject has a history of alcohol abuse (as defined by the current version of the DSM) within 2 years prior to dosing, or positive alcohol test.
- Subject is known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
- Note: Subjects who received hepatitis B vaccination and who test positive for hepatitis B surface antibody and negative for both hepatitis B surface antigen and hepatitis B core antibody remain eligible for study participation.
- Subject smokes > 10 cigarettes per day, or equivalent in other tobacco products including eCigarettes or vapes (self-reported).
- Subject has received immunization with a live or live attenuated vaccine within 2 months prior to dosing or is planning to receive immunization with a live or live attenuated vaccine for 2 months following dosing.
- Subject is part of the study site personnel or a family member of the study site staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Single-Center, Open-Label Study, to Evaluate the Metabolism and Excretion of [14C]-CC-90009 in Healthy Male Subjects
CC-90009-CP-001 is a Phase 1, single-center, open-label, clinical pharmacology study to measure how much CC 90009 gets into the bloodstream, how much is eliminated in urine and stool, and how long it takes the body to get rid of it. In addition, the safety and tolerability of CC 90009 will be evaluated.
Read the detailed description
The primary objective of the study is to characterize the biotransformation and excretion of [14C]-CC-90009 following a single intravenous (IV) dose of 0.6 mg [14C]-CC-90009 in healthy male subjects. The secondary objective of the study is to evaluate the safety and tolerability. The total radioactivity of [14C]-CC-90009 will be 2 μCi.
- Conditions
- Healthy Volunteer
- Being tested
- CC-90009, [14C]
- Keywords
- CC-90009, Metabolism, Healthy Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90009Drug
0.6 mg [ 14C]-CC-90009 administered IV as a single dose
[14C]Radiation
A single dose of [ 14C]-CC-90009 will contain approximately 2 µCi of radioactivity.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-CC-90009 | Experimental | A single IV dose of 0.6 mg [14C]-CC-90009 containing approximately 2 µCi of radioactivity will be administered on Day 1 under fasted conditions. Receives: Drug: CC-90009; Radiation: [14C] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Total [14C]- radioactivity (RA)
Total [14C]-RA in whole blood, plasma, urine, and feces will be measured via LC-AMS
Measured: pre-dose to 240 hours post-dose
Pharmacokinetics - Cumulative excretion of total [14C]-RA
Total RA recovery will be computed as the sum of the cumulative excretion (as % dose) in urine and feces.
Measured: pre-dose to 240 hours post-dose
Pharmacokinetics - Total [14C]-RA whole blood-to-plasma ratios
Ratio of total RA recovery in whole blood compared to in plasma
Measured: pre-dose to 120 hours post-dose
Pharmacokinetics - Cmax
Observed maximum concentration
Measured: pre-dose to 240 hours post-dose
Pharmacokinetics - AUC
Area under the concentration
Measured: pre-dose to 240 hours post-dose
Pharmacokinetics - Tmax
Time to Cmax.
Measured: pre-dose to 240 hours post-dose
Pharmacokinetics - t1/2
Terminal elimination half-life
Measured: pre-dose to 240 hours post-dose
Secondary outcomes (1)
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, 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 the time of informed consent until 28 days after the last dose of study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start11 Mar 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297124
- Sponsor's protocol ID
- CC-90009-CP-001
- Other IDs
- U1111-1248-0508
- Status last verified
- Dec 2021
- First submitted
- 4 Mar 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Open-Label Study, to Evaluate the Metabolism and Excretion of [14C]-CC-90009 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04297124
- Acronym / sponsor ID
- CC-90009-CP-001
- Conditions
- Healthy Volunteer
- Keywords
- CC-90009, Metabolism, Healthy Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 5 Mar 2020 (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.
CC-90009-CP-001 is a Phase 1, single-center, open-label, clinical pharmacology study to measure how much CC 90009 gets into the bloodstream, how much is eliminated in urine and stool, and how long it takes the body to get rid of it. In addition, the safety and tolerability of CC 90009 will be evaluated.
Detailed description
The primary objective of the study is to characterize the biotransformation and excretion of [14C]-CC-90009 following a single intravenous (IV) dose of 0.6 mg [14C]-CC-90009 in healthy male subjects. The secondary objective of the study is to evaluate the safety and tolerability. The total radioactivity of [14C]-CC-90009 will be 2 μCi.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-CC-90009 | Experimental | Drug: CC-90009, Radiation: [14C]A single IV dose of 0.6 mg [14C]-CC-90009 containing approximately 2 µCi of radioactivity will be administered on Day 1 under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Subject is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
- Subject is male.
- 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 is in good health, as determined by the Investigator based on a physical examination at screening.
Key exclusion criteria (23 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 or other study participants at unacceptable risk if he were to participate in the study.
- Subject has a past or current history of any condition affecting calcium homeostasis including, but not limited to: hypocalcemia, parathyroid disorders, vitamin D level lower than 20 ng/mL, disorders of phosphate or magnesium metabolism. The Investigator should contact the Sponsor for questions on any disorders that may be related to calcium homeostasis. Subjects with vitamin D levels < 30 ng/mL are not permitted to serve as sentinel subjects or alternates for the sentinel subjects.
- Subject has a history of prior infusion reactions, anaphylactic reactions, or anaphylactoid reactions to any medication regardless of severity.
- Subject participated in a radiolabeled drug study, where exposures either are known or unknown to the Investigator, within the previous 12 months prior to Day -1. The total 12-month exposure from this study and a maximum of 2 other previous studies within 4 to 12 months of this study will be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1: less than 5,000 mrem whole body annual exposure, with consideration given to the half-lives of the previous radiolabeled study drugs received.
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-900090.6 mg [ 14C]-CC-90009 administered IV as a single dose | Drug | [14C]-CC-90009 |
| [14C]A single dose of [ 14C]-CC-90009 will contain approximately 2 µCi of radioactivity. | Radiation | [14C]-CC-90009 |
Primary outcome
Pharmacokinetics - Total [14C]- radioactivity (RA)
Time frame: pre-dose to 240 hours post-dose
Total [14C]-RA in whole blood, plasma, urine, and feces will be measured via LC-AMS
Pharmacokinetics - Cumulative excretion of total [14C]-RA
Time frame: pre-dose to 240 hours post-dose
Total RA recovery will be computed as the sum of the cumulative excretion (as % dose) in urine and feces.
Pharmacokinetics - Total [14C]-RA whole blood-to-plasma ratios
Time frame: pre-dose to 120 hours post-dose
Ratio of total RA recovery in whole blood compared to in plasma
Pharmacokinetics - Cmax
Time frame: pre-dose to 240 hours post-dose
Observed maximum concentration
Pharmacokinetics - AUC
Time frame: pre-dose to 240 hours post-dose
Area under the concentration
Pharmacokinetics - Tmax
Time frame: pre-dose to 240 hours post-dose
Time to Cmax.
Pharmacokinetics - t1/2
Time frame: pre-dose to 240 hours post-dose
Terminal elimination half-life
1 secondary outcome
Adverse Events (AEs)
Time frame: From the time of informed consent until 28 days after the last dose of study drug.
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 17 Dec 2021.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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-90009 and [14C] in people with Healthy Volunteer, run by Celgene 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 21 inclusion and 23 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 17 Dec 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 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?
Pharmacokinetics - Total [14C]- radioactivity (RA) (time frame: pre-dose to 240 hours post-dose). The study lists 7 primary outcomes in all. 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 17 Dec 2021.