Healthy VolunteersPhase 1NCT01896323
CC-223 and Ketoconazole Drug-Drug Interaction Study
A Phase 1 study testing CC-223 and Ketoconazole in people with Healthy Volunteers, run by Celgene.
Trial summary
This is a single-center open-label study to compare how CC-223 (the study drug being investigated) interacts with the drug ketoconazole. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CC-223 and Ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2013to 1 Aug 2013
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must understand and voluntarily sign a written informed consent form before participation.
- Must be able to communicate with the study doctor, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- Healthy male subject of any race between 18 to 65 years of age, and in good health as determined by a physical examination.
- For males: Agree to use barrier contraception not made of natural (animal) membrane (for example, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of child-bearing potential while on study medication, and for at least 28 days after the last dose of study medication.
- Must have a body mass index between 18 and 33 kilograms/meter squared.
- Clinical laboratory tests must be within normal limits or acceptable to the study doctor.
- Must not have a fever, with a blood pressure between 90/50 to 140/90 millimeters of mercury, and pulse rate: between 40 to 110 beats per minute.
- Must have a normal or clinically acceptable 12-lead electrocardiogram.
Who cannot join
- History of any clinically significant and relevant neurological, 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.
- Used any prescribed or topical medication within one month before the first dose of study drug, unless consultation between the sponsor and the study doctor.
- Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 2 weeks (30 days for St. John's Wort®) of the first dose administration, unless sponsor agreement is obtained.
- Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion of the study drug, for example, bariatric procedure.
- Donated blood or plasma within 2 months before the first dose of study drug.
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- History of drug abuse within 2 years before dosing, or a positive drug screening test reflecting consumption of illicit drugs.
- History of alcohol abuse within 2 years before dosing, or positive alcohol screen.
- Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen, or hepatitis C antibody, or have a positive result to the test for Human Immune virus antibodies at Screening.
- Exposed to an investigational drug within one month 30 days before the first dose of study drug.
- Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products.
About this study
Official title: An Open-Label, Two-Period, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Ketoconazole on the Single Dose Pharmacokinetics of CC-223 in Healthy Adult Male Subjects
This is a single-center open-label study to compare how CC-223 (the study drug being investigated) interacts with the drug ketoconazole.
Read the detailed description
This is a 2 period study, which lasts about 6 weeks long. About 14 males will be entered into the study, during which they will receive the study drug (a single dose of 20 mg CC-223) 400 mg ketoconazole.
- Conditions
- Healthy Volunteers
- Being tested
- CC-223, Ketoconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-223Drug
CC-223 20 mg tablets
KetoconazoleDrug
Also called Nizoral
Ketoconazole 400 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| CC-223 | Experimental | CC-223 administration on study day 1 of Period 1 and study day 5 of Period 2 Receives: Drug: CC-223 |
| Ketokonazole | Active comparator | Ketoconazole administration on study days 1 through 8 of Period 2 Receives: Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
AUC-area under the plasma concentration-time curve;
Measured: up to 96 hours post dose
Pharmacokinetics
Cmax-maximum observed plasma concentration
Measured: up to 96 hours post dose
Pharmacokinetics
Tmax - Time to maximum observed plasma concentration
Measured: up to 96 hours post dose
Pharmacokinetics
t½ - terminal elimination half-life in plasma
Measured: up to 96 hours post dose
Secondary outcomes (1)
Adverse Events
Number of subjects with adverse events
Measured: Up to 28 days after 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 posted11 Jul 2013 (estimated)
- Study start1 Jul 2013
- Primary completion1 Aug 2013
- Study completion1 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward O'Mara, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896323
- Sponsor's protocol ID
- CC-223-CP-003
- Status last verified
- Nov 2019
- First submitted
- 8 Jul 2013
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Tong Z, Narayanan R, Atsriku C, Nissel J, Li Y, Liu H, Wang X, Surapaneni S. Assessment of drug-drug interaction potential and PBPK modeling of CC-223, a potent inhibitor of the mammalian target of rapamycin kinase. Xenobiotica. 2019 Jan;49(1):54-70. doi: 10.1080/00498254.2018.1424377. Epub 2018 Jan 17.
PubMed 29297772
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Period, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Ketoconazole on the Single Dose Pharmacokinetics of CC-223 in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01896323
- Acronym / sponsor ID
- CC-223-CP-003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 1 Aug 2013 (actual)
- Study completion
- 1 Aug 2013 (actual)
- First posted
- 11 Jul 2013 (estimated)
- 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 single-center open-label study to compare how CC-223 (the study drug being investigated) interacts with the drug ketoconazole.
Detailed description
This is a 2 period study, which lasts about 6 weeks long. About 14 males will be entered into the study, during which they will receive the study drug (a single dose of 20 mg CC-223) 400 mg ketoconazole.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CC-223 | Experimental | Drug: CC-223CC-223 administration on study day 1 of Period 1 and study day 5 of Period 2 |
| Ketokonazole | Active comparator | Drug: KetoconazoleKetoconazole administration on study days 1 through 8 of Period 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must understand and voluntarily sign a written informed consent form before participation.
- Must be able to communicate with the study doctor, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- Healthy male subject of any race between 18 to 65 years of age, and in good health as determined by a physical examination.
- Must have a body mass index between 18 and 33 kilograms/meter squared.
- Clinical laboratory tests must be within normal limits or acceptable to the study doctor.
Key exclusion criteria (11 listed)
- History of any clinically significant and relevant neurological, 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.
- Used any prescribed or topical medication within one month before the first dose of study drug, unless consultation between the sponsor and the study doctor.
- Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 2 weeks (30 days for St. John's Wort®) of the first dose administration, unless sponsor agreement is obtained.
- Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion of the study drug, for example, bariatric procedure.
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-223CC-223 20 mg tablets | Drug | CC-223 |
| KetoconazoleAlso: NizoralKetoconazole 400 mg tablets | Drug | Ketokonazole |
Primary outcome
Pharmacokinetics
Time frame: up to 96 hours post dose
AUC-area under the plasma concentration-time curve;
Pharmacokinetics
Time frame: up to 96 hours post dose
Cmax-maximum observed plasma concentration
Pharmacokinetics
Time frame: up to 96 hours post dose
Tmax - Time to maximum observed plasma concentration
Pharmacokinetics
Time frame: up to 96 hours post dose
t½ - terminal elimination half-life in plasma
1 secondary outcome
Adverse Events
Time frame: Up to 28 days after 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 12 Nov 2019.
- Background: PubMed 29297772Tong Z, Narayanan R, Atsriku C, Nissel J, Li Y, Liu H, Wang X, Surapaneni S. Assessment of drug-drug interaction potential and PBPK modeling of CC-223, a potent inhibitor of the mammalian target of rapamycin kinase. Xenobiotica. 2019 Jan;49(1):54-70. doi: 10.1080/00498254.2018.1424377. Epub 2018 Jan 17.
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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.
Edward O'Mara, MD study director
Celgene Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-223 and Ketoconazole in people with Healthy Volunteers, run by Celgene.
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 8 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 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: up to 96 hours post dose). The study lists 4 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 NCT01896323, which also lists 1 linked publication.
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 12 Nov 2019.