Healthy VolunteersPhase 1NCT02168205
Food Effect and CYP1A2 Induction Study in Healthy Subjects
A Phase 1 study testing Pomalidomide, Caffeine and Tobacco in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
This study will evaluate the effect of food and smoking on healthy older subjects taking pomalidomide. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Pomalidomide, Caffeine and Tobacco
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2014to 19 Sep 2014
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1: 1.Must understand and voluntarily sign a written Informed Consent prior to any study-related procedures being performed.
- 2.Must be able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- 3.Must be male or postmenopausal women of any race between ≥61 to ≤85 years of age (inclusive) at the time of signing the Informed Consent, and in good health as determined by a physical exam, clinical laboratory safety test results, vital signs, and 12 lead Electrocardiogram.
- =Naturally postmenopausal for at least 24 consecutive months (ie, who has not had menses at any time in the preceding 24 consecutive months) 4.Subjects must be a non smoker. 5.Clinical laboratory tests must be within normal limits or acceptable to the Principal Investigator (PI).
- 6.Must have a normal or clinically acceptable 12-lead Electrocardiogram. 7.Must be afebrile (febrile is defined as ≥ 38.0ºC or 100.4 Fahrenheit), with supine systolic blood pressure (BP): 90 to 150 mmHg, supine diastolic blood pressure: 60 to 95 mmHg, and pulse rate: 40 to 110 bpm and controlled on medications if they are indicated (especially for blood pressure).
- If a subject has a diagnosis of hypertension, the range for BP and pulse rate will be the one that is considered well controlled on medication.
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- 8.Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female that can get pregnant while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
- = True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Period abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception 9.Must agree to refrain from donating sperm or semen while participating in this study and for at least 28 days following the last dose of study drug.
- 10.Must agree to refrain from donating blood or plasma (other than for this study) while participating in this study and for at least 28 days following the last dose of study drug.
- 11.Must agree to comply with the conditions described in the counseling document (part of the pomalidomide Pregnancy Prevention Risk Management Plan.
- Part 2
- Must understand and voluntarily sign a written informed consent prior to any study-related procedures being performed.
- Must be able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- Must be male of any race between 40 to 80 years of age (inclusive) at the time of signing the Informed Consent, and in good health as determined by a physical exam, clinical laboratory safety test results, vital signs, and 12 lead electrocardiogram.
- Cohort A subjects (smokers) must have a history of smoking for >5 years and currently smoke ≥1 pack (20-25) cigarettes per day; and urine cotinine level at screening and baseline (Day -1) indicate subject is heavy smoker.
- Cohort B subjects (non-smokers) must have not smoked for >5 years (Cohort B).
- Clinical laboratory tests must be within normal limits or acceptable to the Principal Investigator.
- Must have a normal or clinically acceptable 12-lead Electrocardiogram, with a QTcF value ≤ 450 msec.
- Must be afebrile (febrile is defined as ≥ 38.0ºC or 100.4 Fahrenheit), with supine systolic blood pressure (BP): 90 to 150 mmHg, supine diastolic blood pressure: 60 to 95 mmHg, and pulse rate: 40 to 110 bpm and controlled on medications if they are indicated (especially for blood pressure).
- Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female that can get pregnant while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
- Must agree to refrain from donating sperm or semen while participating in this study and for at least 28 days following the last dose of study drug.
- Must agree to refrain from donating blood or plasma (other than for this study) while participating in this study and for at least 28 days following the last dose of study drug.
- Must agree to comply with the conditions described in the counseling document (part of the pomalidomide Pregnancy Prevention Risk Management Plan.
Who cannot join
- Both Parts:
- History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, known hypersensitivity to a member of the class of drugs that can modulate the immune system, or other major disorders.
- Subjects with well-controlled hypertension, hyperlipidemia, gout, asthma/chronic obstructive pulmonary disease, hypothyroidism and other common age-related disorders, requiring treatment and being well-controlled on concomitant prescription medication(s) will be eligible for inclusion in the study.
- Subjects with diabetes, significant gastrointestinal diseases or hematologic disorders should not be included in the study.
- Any condition, including the presence of laboratory abnormalities, 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 systemic or topical medication within 30 days of the first dose administration, unless these medications are chronically administered and Sponsor agreement is obtained.
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- Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration, unless these medications are chronically administered and Sponsor agreement is obtained.
- Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion, e.g., bariatric procedure.
- Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
- History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual within 2 years before dosing, or positive drug screening test reflecting consumption of illicit drugs.
- History of alcohol abuse (as defined by the current version of the DSM) 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 Immunodeficiency Virus antibodies at Screening.
- 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 is longer).
- Received vaccination (excluding seasonal flu vaccination) within 90 days of the study drug administration.
- Subjects who are part of the staff personnel or family members of the investigational study staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
Official title: Hase I Open-Label Two-Part Study To Evaluate The Effect Of Food and Of CYP1A2 Induction On Pomalidomide (CC-4047) Pharmacokinetics in Healthy Subjects
This study will evaluate the effect of food and smoking on healthy older subjects taking pomalidomide.
Read the detailed description
This study will be conducted in two parts. Parts 1 and 2 may be conducted in parallel and subjects are only allowed to participate in one part.
In Part 1, subjects will be randomly assigned to receive a single oral dose of 4 mg pomalidomide on Day 1 under fed (standard high fat breakfast) or fasted conditions. After a washout period of at least 3 and no more than 7 days, subjects will receive a single oral dose of 4 mg pomalidomide under the opposite condition to what they received in the first period.
In Part 2, healthy male smoker subjects must smoke approximately 20 cigarettes per day for a total of 10 days. Non-smokers will neither smoke nor be in the presence of smokers. All subjects will receive orally a 200-mg caffeine capsule on Day 6, and on Day 8, subjects will receive a single oral dose of 4 mg pomalidomide.
For both Parts 1 and 2, serial blood samples will be collected for determination of plasma pomalidomide concentrations.
- Conditions
- Healthy Volunteers
- Being tested
- Pomalidomide, Caffeine, Tobacco
- Keywords
- Healthy volunteer, Pharmacokinetics, Pomalyst, Pomalidomide, Food effect, smoker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
Capsules
CaffeineOther
Capsules
TobaccoOther
Cigarettes
| Study group | Role | What they receive |
|---|---|---|
| 4 mg Pomalidomide - Fed | Experimental | On Day 1, participants will receive a single oral dose of 4 mg pomalidomide under fed conditions. Receives: Drug: Pomalidomide |
| 4 mg Pomalidomide - Fasted | Experimental | On Day 1, participants will receive a single oral dose of 4 mg pomalidomide under fasted conditions Receives: Drug: Pomalidomide |
| 4 mg Pomalidomide + caffeine - Non-smoking | Experimental | Participants will remain in the clinical site for a total of 10 days. They will receive orally a 200-mg caffeine capsule on Day 6, and on Day 8, participants will receive a single oral dose of 4 mg pomalidomide. Receives: Drug: Pomalidomide; Other: Caffeine |
| 4 mg Pomalidomide + caffeine - Smoking | Experimental | Participants will be required to smoke approximately 20 cigarettes a day for 10 days. They will receive orally a 200-mg caffeine capsule on Day 6, and on Day 8, participants will receive a single oral dose of 4 mg pomalidomide. Receives: Drug: Pomalidomide; Other: Caffeine; Other: Tobacco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Maximum observed concentration in plasma
Measured: Up to 8 days for Part 1; up to 10 days for Part 2
Pharmacokinetics - Tmax
Time to maximum observed concentration in plasma
Measured: Up to 8 days for Part 1; up to 10 days for Part 2
Pharmacokinetics - AUC
Area under the plasma concentration-time curve
Measured: Up to 8 days for Part 1; up to 10 days for Part 2
Pharmacokinetics - T1/2
Terminal half-life
Measured: Up to 8 days for Part 1; up to 10 days for Part 2
Pharmacokinetics - Vz/f
Apparent volume of distribution
Measured: Up to 8 days for Part 1; up to 10 days for Part 2
Pharmacokinetics - CL/F
Apparent total body clearance
Measured: Up to 8 days for Part 1; up to 10 days for Part 2
Secondary outcomes (1)
Adverse events
Number of participants with adverse events
Measured: Approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study start30 May 2014
- Primary completion19 Sep 2014
- Study completion19 Sep 2014
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 55 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168205
- Sponsor's protocol ID
- CC-4047-CP-011
- Status last verified
- Nov 2018
- First submitted
- 18 Jun 2014
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hase I Open-Label Two-Part Study To Evaluate The Effect Of Food and Of CYP1A2 Induction On Pomalidomide (CC-4047) Pharmacokinetics in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02168205
- Acronym / sponsor ID
- CC-4047-CP-011
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteer, Pharmacokinetics, Pomalyst, Pomalidomide, Food effect, smoker
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 30 May 2014 (actual)
- Primary completion
- 19 Sep 2014 (actual)
- Study completion
- 19 Sep 2014 (actual)
- First posted
- 20 Jun 2014 (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 study will evaluate the effect of food and smoking on healthy older subjects taking pomalidomide.
Detailed description
This study will be conducted in two parts. Parts 1 and 2 may be conducted in parallel and subjects are only allowed to participate in one part.
In Part 1, subjects will be randomly assigned to receive a single oral dose of 4 mg pomalidomide on Day 1 under fed (standard high fat breakfast) or fasted conditions. After a washout period of at least 3 and no more than 7 days, subjects will receive a single oral dose of 4 mg pomalidomide under the opposite condition to what they received in the first period.
In Part 2, healthy male smoker subjects must smoke approximately 20 cigarettes per day for a total of 10 days. Non-smokers will neither smoke nor be in the presence of smokers. All subjects will receive orally a 200-mg caffeine capsule on Day 6, and on Day 8, subjects will receive a single oral dose of 4 mg pomalidomide.
For both Parts 1 and 2, serial blood samples will be collected for determination of plasma pomalidomide concentrations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4 mg Pomalidomide - Fed | Experimental | Drug: PomalidomideOn Day 1, participants will receive a single oral dose of 4 mg pomalidomide under fed conditions. |
| 4 mg Pomalidomide - Fasted | Experimental | Drug: PomalidomideOn Day 1, participants will receive a single oral dose of 4 mg pomalidomide under fasted conditions |
| 4 mg Pomalidomide + caffeine - Non-smoking | Experimental | Drug: Pomalidomide, Other: CaffeineParticipants will remain in the clinical site for a total of 10 days. They will receive orally a 200-mg caffeine capsule on Day 6, and on Day 8, participants will receive a single oral dose of 4 mg pomalidomide. |
| 4 mg Pomalidomide + caffeine - Smoking | Experimental | Drug: Pomalidomide, Other: Caffeine, Other: TobaccoParticipants will be required to smoke approximately 20 cigarettes a day for 10 days. They will receive orally a 200-mg caffeine capsule on Day 6, and on Day 8, participants will receive a single oral dose of 4 mg pomalidomide. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Part 1: 1.Must understand and voluntarily sign a written Informed Consent prior to any study-related procedures being performed.
- 2.Must be able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- 3.Must be male or postmenopausal women of any race between ≥61 to ≤85 years of age (inclusive) at the time of signing the Informed Consent, and in good health as determined by a physical exam, clinical laboratory safety test results, vital signs, and 12 lead Electrocardiogram.
- 6.Must have a normal or clinically acceptable 12-lead Electrocardiogram. 7.Must be afebrile (febrile is defined as ≥ 38.0ºC or 100.4 Fahrenheit), with supine systolic blood pressure (BP): 90 to 150 mmHg, supine diastolic blood pressure: 60 to 95 mmHg, and pulse rate: 40 to 110 bpm and controlled on medications if they are indicated (especially for blood pressure).
- 8.Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female that can get pregnant while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
Key exclusion criteria (15 listed)
- Both Parts:
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 |
|---|---|---|
| PomalidomideCapsules | Drug | 4 mg Pomalidomide + caffeine - Non-smoking, 4 mg Pomalidomide + caffeine - Smoking, 4 mg Pomalidomide - Fasted, 4 mg Pomalidomide - Fed |
| CaffeineCapsules | Other | 4 mg Pomalidomide + caffeine - Non-smoking, 4 mg Pomalidomide + caffeine - Smoking |
| TobaccoCigarettes | Other | 4 mg Pomalidomide + caffeine - Smoking |
Primary outcome
Pharmacokinetics - Cmax
Time frame: Up to 8 days for Part 1; up to 10 days for Part 2
Maximum observed concentration in plasma
Pharmacokinetics - Tmax
Time frame: Up to 8 days for Part 1; up to 10 days for Part 2
Time to maximum observed concentration in plasma
Pharmacokinetics - AUC
Time frame: Up to 8 days for Part 1; up to 10 days for Part 2
Area under the plasma concentration-time curve
Pharmacokinetics - T1/2
Time frame: Up to 8 days for Part 1; up to 10 days for Part 2
Terminal half-life
Pharmacokinetics - Vz/f
Time frame: Up to 8 days for Part 1; up to 10 days for Part 2
Apparent volume of distribution
Pharmacokinetics - CL/F
Time frame: Up to 8 days for Part 1; up to 10 days for Part 2
Apparent total body clearance
1 secondary outcome
Adverse events
Time frame: Approximately 1 month
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 15 Nov 2018.
- Related InfoLink provided by the sponsor.
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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
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 Pomalidomide, Caffeine and Tobacco in people with Healthy Volunteers, 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 23 inclusion and 15 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 15 Nov 2018. 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 - Cmax (time frame: Up to 8 days for Part 1; up to 10 days for Part 2). The study lists 6 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 15 Nov 2018.