Clinical Pharmacology, Healthy Volunteer StudyPhase 1NCT01835561
Study to Evaluate Pharmacokinetics of Pomalidomide in Hepatically Impaired Males
A Phase 1 study testing Pomalidomide in people with Clinical Pharmacology, Healthy Volunteer Study, run by Celgene at 2 sites in United States.
Trial summary
This study is for research purposes only and will not treat any disease or condition you may have. The study is an open label and single dose study; open label means that you, the study doctor and study staff will know which study drug you are taking. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Pharmacology, Healthy Volunteer Study
- What is being tested?
- Pomalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2013to 21 Aug 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 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion Criteria for Matched Healthy Subjects (Group 1):
- Must understand and voluntarily sign a written informed consent document (ICD) 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 subjects of any race between 18 to 70 years of age, inclusive, with a body mass index between 18 and 37 kg/m2 (inclusive).
- Subjects must be in good health (at screening and baseline [Day -1]) as determined by the investigator on the basis of medical history, physical examination, clinical laboratory safety test results, vital signs, and 12 lead ECG.
- Clinical laboratory safety tests must be within normal limits or acceptable to the investigator (at screening and baseline [Day -1]), and in particular:
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- Creatinine less than or equal to 1.5x upper limit of normal (ULN)
- Must be afebrile, with supine (after the subject has rested for at least 5 minutes) systolic blood pressure: 90 to 140 mmHg, supine diastolic blood pressure: 60 to 90 mmHg, and pulse rate: 40 to 110 bpm.
- Must have a normal or clinically acceptable 12-lead ECG. Male subjects must have a QTcF value ≤ 430 msec.
- Subjects (with or without vasectomy) must practice true abstinence* or agree to use double barrier contraception (ie, latex condom or any non-latex condom not made out of natural [animal] membrane [eg, polyurethane]) and one other method (eg, spermicide) when engaging in sexual activity with woman of child-bearing potential during study conduct, and for 28 days after the last dose of study medication.
- True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
- Must agree to refrain from donating sperm, blood or plasma (other than for this study) while participating in this study and for at least 28 days after the last dose of study drug.
- Subjects who have not performed strenuous physical activity for at least 72 hours prior to the dose of study drug and agree to not engage in strenuous physical activity throughout the study and until study completion (follow-up safety telephone call).
- Will be counseled about pregnancy precautions and risks of fetal exposure and agree to comply with the conditions described in the counseling document.
- Inclusion Criteria for All Hepatically Impaired Subjects (Groups 2, 3 and 4):
- Must understand and voluntarily sign a written informed consent form (ICF) 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.
- Male subjects of any race between 18 to 70 years of age, inclusive, with a body mass index between 18 and 37 kg/m2 (inclusive).
- Subjects must have severe, moderate, or mild hepatic impairment or cirrhosis due to chronic hepatic diseases and/or prior alcohol abuse (Groups 2, 3 and 4, respectively).
- Creatinine less than or equal to 1.5X ULN.
- Subjects should be enrolled into the group corresponding to the Child-Pugh classification score that most accurately reflects the most severe hepatic disease classification within the past 6 months (based upon past medical history or physical examination observations). Adequate documentation should be provided to substantiate the Child-Pugh score assigned to each subject.
- For Group 2 (severe hepatic impairment), if biopsy, laparoscopy or ultrasound is not performed prior to screening, subjects can be included only if they have chronic liver disease and objective evidence of portal hypertension (ascites diagnosed by imaging or varices), with a Child-Pugh score ≥10 and ≤13.
- Subjects in Group 3 (moderate hepatic impairment) are required to have confirmation of the diagnosis of cirrhosis made by biopsy, laparoscopy or ultrasound with a Child-Pugh score of 7 to 9, inclusive.
- Subjects in Group 4 (mild hepatic impairment) are required to have confirmation of the diagnosis of cirrhosis made by biopsy laparoscopy or ultrasound with a Child- Pugh score of 5 to 6, inclusive.
- Subjects may be treated with diuretics for ascites; however, subjects with severe ascites at time of enrollment may only be included at the discretion of the investigator with agreement of the Sponsor.
- Subjects must not have history of hepatorenal syndrome or hemolysis.
- Subjects (with or without vasectomy) must practice true abstinence* or agree to use double barrier contraception (ie, latex condom or any non-latex condom not made out of natural [animal] membrane [eg, polyurethane]) and one other method (eg, spermicide) when engaging in sexual activity with woman of child-bearing potential during study conduct, and for 28 days after the last dose of study medication.
- True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- Must agree to refrain from donating sperm, blood or plasma (other than for this study) while participating in this study and for at least 28 days after the last dose of study drug.
- Will be counseled about pregnancy precautions and risks of fetal exposure and agree to comply with the conditions described in the counseling document .
- Subjects are medically stable for at least 1 month before pomalidomide administration with clinically acceptable physical exam, clinical lab tests, vital signs, and 12-lead ECG consistent with the underlying stable mild, moderate or severe impaired liver condition as judged by the investigator.
- Subjects must be free of acute major illness within one month prior to dosing or acute illness within 14 days prior to dosing, with the exception of hepatic impairment and related illnesses as judged by the investigator.
- Subjects who have not performed strenuous physical activity for at least 72 hours prior to the dose of study drug and agree to not engage in strenuous physical activity throughout the study and until study completion (follow-up safety telephone call).
Who cannot join
- 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 IMiDs, 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 systemic or topical medication within 30 days of the first dose administration, unless Sponsor agreement is obtained.
- Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration, unless Sponsor agreement is obtained.
- Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME), including but not limited to: bariatric procedure, irritable bowel syndrome (IBS), peptic ulcer(s),cholecystectomy, and chronic liver disease.
- Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
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- History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual (DSM) 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 (HBsAg), or hepatitis C antibody, or have a positive result to the test for HIV 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).
- Smokes more than 10 cigarettes, or consumes the equivalent in tobacco, per day.
- Subjects who are part of the staff personnel or family members of the investigational study staff.
- Subjects who, for any reason, are deemed by the investigator to be inappropriate for this study, including subjects who are unable to communicate or to cooperate with the investigator or the clinical staff.
- Exclusion Criteria for Hepatically Impaired Subject (Groups 2, 3 and 4)
- Any serious medical condition (excluding hepatic impairment and related complications), clinically significant laboratory abnormality not related to hepatic impairment and related complications, or psychiatric illness that would prevent the subject from signing the ICD and participating in the study.
- Any unstable clinically significant illness other than moderate or severe hepatic impairment within 3 months prior to the subject signing the ICD.
- Hepatic encephalopathy with time-disorientation, somnolent, stuporous, place disorientation, hyperactive reflexes, rigidity, slower electroencephalography (EEG) waves, unrousable coma, no personality/behavior, decerebrate, and slow 2-3 counts per second (cps) delta activity.
- Have a positive test result for Human Immunodeficiency Virus (HIV) antibodies.
- 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 (DSM) within 2 years before dosing, or positive drug screening test reflecting consumption of illicit drugs.
- 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).
- Smokes more than 10 cigarettes, or consumes the equivalent in tobacco, per day.
- Subjects who are part of the staff personnel or family members of the investigational study staff.
- Subjects who, for any reason, are deemed by the investigator to be inappropriate for this study, including subjects who are unable to communicate or to cooperate with the investigator or the clinical staff.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics of Pomalidomide (CC-4047) in Hepatically Impaired Male Subjects
This study is for research purposes only and will not treat any disease or condition you may have. The study is an open label and single dose study; open label means that you, the study doctor and study staff will know which study drug you are taking.
The purpose of this research study is to compare drug levels in the body of people with liver disease to drug levels in healthy people with a normal liver. In addition, the safety of the study drug will be studied. Information about any side effects (discomfort or decline in health) that may happen will be collected. The study drug will be given by mouth to subjects with liver disease and to healthy subjects.
Read more
In the body, drugs are normally removed by the liver with a smaller amount being removed by the kidneys. When the liver is not working as well as it should, the body may not be able to remove drugs from the body quickly.
The information from this study will be used to decide if the drug is safe in subjects with liver disease or if a lower dose of the study drug would be safer.
Read the detailed description
The study will be conducted at more than one clinical site (2-3 clinical research sites) and designed to assess the impact of severe liver disease or hepatic impairment (Part 1, Group 1) on the PK of pomalidomide following oral administration of a single dose of 4 mg pomalidomide (the study drug). The study drug, pomalidomide (POMALYST®), has been approved by the United States Food and Drug Administration (FDA) to treat patients with multiple myeloma (MM). Patients with MM have bone marrow that produces a large number of abnormal cells. Pomalidomide is only available by prescription.
Since participants in this study do not have MM, pomalidomide is considered experimental for the purposes of this research study. Throughout this form, pomalidomide will be referred to as "the study drug."
Participation in this study will be in either the healthy group or the group with liver disease. For the group with the liver disease,the liver disease will be graded by the study doctor as being "severe," "moderate," or "mild." This will be done by the study doctor depending on medical history, physical examination, laboratory tests, and certain previous results of liver scans or liver biopsy.
The amount of the study drug in blood will be measured at certain times to how well the drug is broken-down or removed from the body. Blood samples approximately 1 teaspoon (approximately 5-6 mL) will be collected 13 times the following times to measure study drug levels in your blood:
- Predose (just before dosing), and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, and 48 hours after dose pomalidomide morning dose on Day 1.
This study will have two parts:
Part 1 will evaluate the study drug in subjects with severe liver disease (Group and healthy volunteer subjects (Group 1) matched to the subjects with liver disease. Part 2 will evaluate the study drug in subjects with moderate (Group 3) and/ mild (Group 4) liver disease.
Study participation will be in one part only (either Part 1 or Part 2). Part be conducted after the data from Part 1 is analyzed and reviewed and the doctor and the sponsor determine that there is a need to conduct Part 2.
The purposes of this study are:
- To measure and compare the levels of pomalidomide in the blood of male subjects with severe liver disease and their matched healthy volunteer subjects after taking one 4-mg capsule of pomalidomide.
- To measure and compare the levels of pomalidomide in the blood of male subjects with moderate or mild liver disease after taking one 4-mg capsule of pomalidomide.
- To study the impact of liver disease on the safety of a single dose of pomalidomide in male subjects with liver disease.
Approximately 16 male subjects will be enrolled in Part 1 of the study (8 healthy subjects and 8 subjects with severe liver disease). Approximately 16 male subjects will be in Part 2 of the study (8 subjects with mild liver disease and subjects with moderate liver disease). If both parts of the study are completed, a total of about 32 male subjects will be enrolled. The total time a participant will be in the study is about 1 month (from screening visit to end of study).
- Being tested
- Pomalidomide
- Keywords
- Hepatic, Liver disease; Pharmacokinetic; Healthy
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
Also called POMALYST®
Single oral dose of 4-mg capsule
PomalidomideDrug
Also called POMALYST®
4-mg capsule
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Severe liver disease and healthy volunteer match | Experimental | Subjects with severe liver disease (Group 2) and healthy volunteer subjects (Group 1) matched to the subjects with liver disease Receives: Drug: Pomalidomide |
| Part 2: Mild and moderate Liver disease | Experimental | Subjects with moderate (Group 3) and/or mild (Group 4) liver disease Receives: Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
C max
Observed maximum concentration; PK parameter for plasma pomalidomide
Measured: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
T max
Time to Cmax
Measured: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
Area Under the Curve Time Zero to time(AUC0-t)
Area under the plasma concentration-time curve from time zero to time t, where t is the last measurable time point
Measured: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
Area Under the Curve (AUCinf) ; from time 0 to infinity
Area under the plasma concentration-time curve from time zero extrapolated to infinity; PK parameter for plasma pomalidomide
Measured: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
t ½: Terminal Half Life
Estimate of the terminal elimination half-life in plasma 5. delay between time of administration and absorption
Measured: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
CL/F: apparent clearance
Apparent total plasma or serum clearance of drug after oral administration
Measured: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
Vz/F: apparent volume of distribution
Apparent volume of distribution during terminal phase after oral / extravascular administration
Measured: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
Secondary outcomes (1)
Number of participants with adverse events (AEs).
An adverse event (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 below), 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: 1 month (from screening visit to end of study follow-up telephone call).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study start1 Mar 2013
- Primary completion16 Aug 2014
- Study completion21 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Pharmacology, Healthy Volunteer StudyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT01835561
- Sponsor's protocol ID
- CC-4047-CP-009
- Status last verified
- Nov 2019
- First submitted
- 17 Apr 2013
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
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
- A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics of Pomalidomide (CC-4047) in Hepatically Impaired Male Subjects
- ClinicalTrials.gov ID
- NCT01835561
- Acronym / sponsor ID
- CC-4047-CP-009
- Keywords
- Hepatic, Liver disease; Pharmacokinetic; Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 16 Aug 2014 (actual)
- Study completion
- 21 Aug 2014 (actual)
- First posted
- 19 Apr 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 study is for research purposes only and will not treat any disease or condition you may have. The study is an open label and single dose study; open label means that you, the study doctor and study staff will know which study drug you are taking.
The purpose of this research study is to compare drug levels in the body of people with liver disease to drug levels in healthy people with a normal liver. In addition, the safety of the study drug will be studied. Information about any side effects (discomfort or decline in health) that may happen will be collected. The study drug will be given by mouth to subjects with liver disease and to healthy subjects.
In the body, drugs are normally removed by the liver with a smaller amount being removed by the kidneys. When the liver is not working as well as it should, the body may not be able to remove drugs from the body quickly.
The information from this study will be used to decide if the drug is safe in subjects with liver disease or if a lower dose of the study drug would be safer.
Detailed description
The study will be conducted at more than one clinical site (2-3 clinical research sites) and designed to assess the impact of severe liver disease or hepatic impairment (Part 1, Group 1) on the PK of pomalidomide following oral administration of a single dose of 4 mg pomalidomide (the study drug). The study drug, pomalidomide (POMALYST®), has been approved by the United States Food and Drug Administration (FDA) to treat patients with multiple myeloma (MM). Patients with MM have bone marrow that produces a large number of abnormal cells. Pomalidomide is only available by prescription.
Since participants in this study do not have MM, pomalidomide is considered experimental for the purposes of this research study. Throughout this form, pomalidomide will be referred to as "the study drug."
Participation in this study will be in either the healthy group or the group with liver disease. For the group with the liver disease,the liver disease will be graded by the study doctor as being "severe," "moderate," or "mild." This will be done by the study doctor depending on medical history, physical examination, laboratory tests, and certain previous results of liver scans or liver biopsy.
The amount of the study drug in blood will be measured at certain times to how well the drug is broken-down or removed from the body. Blood samples approximately 1 teaspoon (approximately 5-6 mL) will be collected 13 times the following times to measure study drug levels in your blood:
- Predose (just before dosing), and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, and 48 hours after dose pomalidomide morning dose on Day 1.
This study will have two parts:
Part 1 will evaluate the study drug in subjects with severe liver disease (Group and healthy volunteer subjects (Group 1) matched to the subjects with liver disease. Part 2 will evaluate the study drug in subjects with moderate (Group 3) and/ mild (Group 4) liver disease.
Study participation will be in one part only (either Part 1 or Part 2). Part be conducted after the data from Part 1 is analyzed and reviewed and the doctor and the sponsor determine that there is a need to conduct Part 2.
The purposes of this study are:
- To measure and compare the levels of pomalidomide in the blood of male subjects with severe liver disease and their matched healthy volunteer subjects after taking one 4-mg capsule of pomalidomide.
- To measure and compare the levels of pomalidomide in the blood of male subjects with moderate or mild liver disease after taking one 4-mg capsule of pomalidomide.
- To study the impact of liver disease on the safety of a single dose of pomalidomide in male subjects with liver disease.
Approximately 16 male subjects will be enrolled in Part 1 of the study (8 healthy subjects and 8 subjects with severe liver disease). Approximately 16 male subjects will be in Part 2 of the study (8 subjects with mild liver disease and subjects with moderate liver disease). If both parts of the study are completed, a total of about 32 male subjects will be enrolled. The total time a participant will be in the study is about 1 month (from screening visit to end of study).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Severe liver disease and healthy volunteer match | Experimental | Drug: PomalidomideSubjects with severe liver disease (Group 2) and healthy volunteer subjects (Group 1) matched to the subjects with liver disease |
| Part 2: Mild and moderate Liver disease | Experimental | Drug: PomalidomideSubjects with moderate (Group 3) and/or mild (Group 4) liver disease |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Inclusion Criteria for Matched Healthy Subjects (Group 1):
- Must understand and voluntarily sign a written informed consent form (ICF) 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.
- Male subjects of any race between 18 to 70 years of age, inclusive, with a body mass index between 18 and 37 kg/m2 (inclusive).
- Subjects must have severe, moderate, or mild hepatic impairment or cirrhosis due to chronic hepatic diseases and/or prior alcohol abuse (Groups 2, 3 and 4, respectively).
Key exclusion criteria (24 listed)
- Exclusion Criteria for Hepatically Impaired Subject (Groups 2, 3 and 4)
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 |
|---|---|---|
| PomalidomideAlso: POMALYST®Single oral dose of 4-mg capsule | Drug | Part 1: Severe liver disease and healthy volunteer match |
| PomalidomideAlso: POMALYST®4-mg capsule | Drug | Part 2: Mild and moderate Liver disease |
Primary outcome
C max
Time frame: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
Observed maximum concentration; PK parameter for plasma pomalidomide
T max
Time frame: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
Time to Cmax
Area Under the Curve Time Zero to time(AUC0-t)
Time frame: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
Area under the plasma concentration-time curve from time zero to time t, where t is the last measurable time point
Area Under the Curve (AUCinf) ; from time 0 to infinity
Time frame: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
Area under the plasma concentration-time curve from time zero extrapolated to infinity; PK parameter for plasma pomalidomide
t ½: Terminal Half Life
Time frame: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
Estimate of the terminal elimination half-life in plasma 5. delay between time of administration and absorption
CL/F: apparent clearance
Time frame: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
Apparent total plasma or serum clearance of drug after oral administration
Vz/F: apparent volume of distribution
Time frame: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 hours post dose
Apparent volume of distribution during terminal phase after oral / extravascular administration
1 secondary outcome
Number of participants with adverse events (AEs).
Time frame: 1 month (from screening visit to end of study follow-up telephone call).
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.
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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
2 sites 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 in people with Clinical Pharmacology, Healthy Volunteer Study, run by Celgene at 2 sites 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 33 inclusion and 24 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.
Where is the study taking place?
The record lists 2 sites 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?
C max (time frame: At predose (0-hour) and at 0.25, 1, 2, 2.5, 4, 6, 8, 12, 24, 30, 40 and 48 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 12 Nov 2019.