Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-28 @ 12:28 PM
Study NCT ID:
NCT01835561
Status:
COMPLETED
Last Update Posted:
2019-11-12
First Post:
2013-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Pharmacokinetics of Pomalidomide in Hepatically Impaired Males
Sponsor:
Celgene
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics of Pomalidomide (CC-4047) in Hepatically Impaired Male Subjects
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: