Healthy VolunteerPhase 1NCT04655898
Metabolism and Excretion of [14C]CC-90001 in Healthy Male Subjects
A Phase 1 study testing [14C]CC-90001 in people with Healthy Volunteer, run by Celgene at 1 site in United States.
Trial summary
This is a clinical pharmacology study to characterize the biotransformation and excretion of [14C]CC-90001 and to evaluate the safety and tolerability of [14C]CC-90001 following a single oral dose of [14C]CC-90001 in healthy male subjects. 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?
- [14C]CC-90001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2020to 11 Mar 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, from any race, at the time of signing the informed consent form (ICF).
- Subject is a 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 examinations and laboratory testing at screening or at check-in.
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- Must practice true abstinence 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 childbearing potential (FCBP) on the day of taking the single dose of study drug and for at least 90 days after taking the single dose of study drug. This also applies to those subjects who have had a successful vasectomy.
- Subject has a body mass index (BMI) ≥ 18 and ≤ 33kg/m2 at screening.
- Subject is afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 160mmHg, supine diastolic BP ≥ 50 and ≤ 100 mmHg, and pulse rate ≥ 40 and ≤ 90bpm at screening and check-in.
- Subject has screening laboratory test results within the reference range or, if outside the reference range, documented to be not clinically significant by the Investigator.
- Subject has a normal or clinically acceptable 12-lead electrocardiogram (ECG), with a QT interval corrected using Fredericia formula (QTcF) value ≤ 450 msec, at screening and check-in
Who cannot join
- Subject has any significant medical condition, laboratory observation, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including a laboratory test result which places the subject at unacceptable risk if he were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject was exposed to an investigational drug (new chemical entity) within 30days prior to dosing, or 5half-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 7days prior to dosing.
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- Subject has used CYP3A inducers and/or inhibitors (including St. John's Wort) within 30days prior to dosing. The Indiana University "Cytochrome P450 Drug Interaction Table" should be utilized to determine inducers and/or inhibitors of CYP3A (http://medicine.iupui.edu/clinpharm/ddis/table.aspx). Please consult the medical monitor for any uncertainties with regard to potential CYP3A modulators.
- Subject has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure or Gilbert's syndrome.
- Note: prior appendectomy is acceptable, but prior cholecystectomy would result in exclusion from the study. Please consult the medical monitor for uncertainties around the relevance of prior surgical procedures.
- Has donated blood or plasma within 2weeks 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 [DSM]) within 2 years prior to dosing, or positive drug test reflecting consumption of drugs of abuse.
- 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.
- Positive SARS-CoV-2 (severe acute respiratory syndrome coronavirus) test or signs/symptoms of COVID-19 (Coronavirus Disease 2019) infection.
- Subject is known to have serum hepatitis or be a carrier of Hepatitis B virus (HBV) or Hepatitis C virus (HCV); or express 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.
- Smokers or users of other tobacco products (self-reported).
- Subject has received immunization with a live or live attenuated vaccine within 1 months prior to dosing or is planning to receive immunization with a live or live attenuated vaccine for 1months following dosing.
- Subjects who have participated in more than one other radiolabeled investigational drug study within 12 months prior to Check-in (Day-1).
- Note: The previous radiolabeled investigational drug must have been received more than 6 months prior to check-in (Day-1) and the total planned exposure from this current study and the previous study must be within the recommended levels considered safe, per US code of federal regulations (CFR) governing Protection of Human Subjects; radioactive drugs for certain research uses (ie, less than 5000 mrem whole body annual exposure; 21CFR361.1).
- Subject was exposed to serial X-ray or computed tomography scans, barium meal, or employment in a job requiring radiation exposure monitoring within 12 months prior to Day-1.
- History of less than 1 to 2 bowel movements per day.
- 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 Exception of [14C]-CC-90001 in Healthy Male Subjects
This is a clinical pharmacology study to characterize the biotransformation and excretion of [14C]CC-90001 and to evaluate the safety and tolerability of [14C]CC-90001 following a single oral dose of [14C]CC-90001 in healthy male subjects. Approximately 8 subjects will be enrolled into the study with a goal of 6 subjects being eligible for analysis.
- Conditions
- Healthy Volunteer
- Being tested
- [14C]CC-90001
- Keywords
- Mass balance, Males, Healthy volunteers, CC-90001, [14C]CC-90001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]CC-90001Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Administration of [14C]CC-90001 | Experimental | A single oral dose of [14C]CC-90001, containing approximately 100 μCi of radioactivity, will be administered on Day1 under fasted conditions. Receives: Drug: [14C]CC-90001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Total [14C]-RA
Total [14C]-Radioactivity (RA) in whole blood, plasma, urine, and feces) will be measured via Liquid scintillation counting (LSC)
Measured: Up to approximately 216 hours post dose
Pharmacokinetics - Cumulative excretion of total [14C]-RA
The total recovery of radioactivity will be computed as the sum of the cumulative excretion (as % dose) in urine and feces
Measured: Up to approximately 13 days
Pharmacokinetics - Total [14C]-RA whole blood-to-plasma ratios
Total [14C]-RA in whole blood and plasma will be converted to ngEq/mL concentration of [14C]CC-90001 based on specific activity of the dose. Equivalent concentration-time profiles will be determined.
Measured: Up to approximately 216 hours post
Pharmacokinetics - metabolite profiling in plasma
The RA will be determined for CC-90001 and any identified metabolites in plasma. Metabolite profiling may use pooled time points.
Measured: Up to approximately 216 hours post
Pharmacokinetics - metabolite profiling in urine and feces
Percentage of the administered dose, and the RA, will be determined for CC-90001 and any identified metabolites in urine and feces. Metabolite profiling may use pooled collection intervals.
Measured: Up to approximately 13 days
Pharmacokinetics - Cmax
Observed maximum concentration of [14C]CC-90001 and for metabolites with sufficient measurable concentration
Measured: Up to approximately 216 hours post
Pharmacokinetics - AUC
Area under the concentration-time curve of [14C]CC-90001 and for metabolites with sufficient measureable concentration
Measured: Up to approximately 216 hours post
Pharmacokinetics - Tmax
Time to Cmax of [14C]CC-90001 and for metabolites with sufficient measureable concentration
Measured: Up to approximately 216 hours post
Pharmacokinetics - t1/2
Terminal elimination half-life of [14C]CC-90001 and for metabolites with sufficient measureable concentration
Measured: Up to approximately 216 hours post
Secondary outcomes (1)
Number of treatment-emergent adverse event related to CC-90001
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 enrollment until at least 28 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start16 Dec 2020
- Primary completion11 Mar 2021
- Study completion11 Mar 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
- Leon Carayannopoulos, MD, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655898
- Sponsor's protocol ID
- CC-90001-CP-007
- Other IDs
- U1111-1261-4819
- Status last verified
- Jun 2021
- First submitted
- 3 Dec 2020
- Last updated
- 25 Jun 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 25 Jun 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 Exception of [14C]-CC-90001 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04655898
- Acronym / sponsor ID
- CC-90001-CP-007
- Conditions
- Healthy Volunteer
- Keywords
- Mass balance, Males, Healthy volunteers, CC-90001, [14C]CC-90001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 7 Dec 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.
This is a clinical pharmacology study to characterize the biotransformation and excretion of [14C]CC-90001 and to evaluate the safety and tolerability of [14C]CC-90001 following a single oral dose of [14C]CC-90001 in healthy male subjects. Approximately 8 subjects will be enrolled into the study with a goal of 6 subjects being eligible for analysis.
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 [14C]CC-90001 | Experimental | Drug: [14C]CC-90001A single oral dose of [14C]CC-90001, containing approximately 100 μCi of radioactivity, will be administered on Day1 under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject is ≥18 and ≤55 years of age, from any race, at the time of signing the informed consent form (ICF).
- Subject is a 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 examinations and laboratory testing at screening or at check-in.
Key exclusion criteria (21 listed)
- Subject has any significant medical condition, laboratory observation, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including a laboratory test result which places the subject at unacceptable risk if he were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject was exposed to an investigational drug (new chemical entity) within 30days prior to dosing, or 5half-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.
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 |
|---|---|---|
| [14C]CC-90001Oral | Drug | Administration of [14C]CC-90001 |
Primary outcome
Pharmacokinetics - Total [14C]-RA
Time frame: Up to approximately 216 hours post dose
Total [14C]-Radioactivity (RA) in whole blood, plasma, urine, and feces) will be measured via Liquid scintillation counting (LSC)
Pharmacokinetics - Cumulative excretion of total [14C]-RA
Time frame: Up to approximately 13 days
The total recovery of radioactivity 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: Up to approximately 216 hours post
Total [14C]-RA in whole blood and plasma will be converted to ngEq/mL concentration of [14C]CC-90001 based on specific activity of the dose. Equivalent concentration-time profiles will be determined.
Pharmacokinetics - metabolite profiling in plasma
Time frame: Up to approximately 216 hours post
The RA will be determined for CC-90001 and any identified metabolites in plasma. Metabolite profiling may use pooled time points.
Pharmacokinetics - metabolite profiling in urine and feces
Time frame: Up to approximately 13 days
Percentage of the administered dose, and the RA, will be determined for CC-90001 and any identified metabolites in urine and feces. Metabolite profiling may use pooled collection intervals.
Pharmacokinetics - Cmax
Time frame: Up to approximately 216 hours post
Observed maximum concentration of [14C]CC-90001 and for metabolites with sufficient measurable concentration
Pharmacokinetics - AUC
Time frame: Up to approximately 216 hours post
Area under the concentration-time curve of [14C]CC-90001 and for metabolites with sufficient measureable concentration
Pharmacokinetics - Tmax
Time frame: Up to approximately 216 hours post
Time to Cmax of [14C]CC-90001 and for metabolites with sufficient measureable concentration
Pharmacokinetics - t1/2
Time frame: Up to approximately 216 hours post
Terminal elimination half-life of [14C]CC-90001 and for metabolites with sufficient measureable concentration
1 secondary outcome
Number of treatment-emergent adverse event related to CC-90001
Time frame: From enrollment until at least 28 days after completion of study treatment
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 25 Jun 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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Screening Protocol
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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.
Leon Carayannopoulos, MD 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 [14C]CC-90001 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 11 inclusion and 21 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 25 Jun 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]-RA (time frame: Up to approximately 216 hours post dose). The study lists 9 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 25 Jun 2021.