Ignite Creation Date:
2024-05-06 @ 12:37 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01611467
Status:
COMPLETED
Last Update Posted:
2019-11-12
First Post:
2012-05-25
Brief Title:
A Phase 1 Open-Label Study to Evaluate the Metabolism and Excretion of CC-223 and the Effect of Food on the Pharmacokinetics of CC-223 in Healthy Male Adult Subjects
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 1 Open-Label Study to Evaluate the Metabolism and Excretion of CC-223 and the Effect of Food on the Pharmacokinetics of CC-223 in Healthy Male Adult 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:
AMEFE
Brief Summary:
Part 1 To characterize the biotransformation and excretion of CC-223 following a single 20-mg oral dose of CC-223 capsule containing a microtracer of 14C-CC-223 solution in healthy male subjects and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 capsule containing a microtracer of 14C-CC-223 solution in healthy male adult subjects Part 2 To evaluate the effect of a high-fat meal on the pharmacokinetics PK of CC-223 following a single 20-mg oral dose of CC-223 tablet To evaluate the effect of a high-fat meal on the PK of M1 the principal pharmacologically-active metabolite following a single 20-mg oral dose of CC-223 tablet and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 tablet in healthy male adult subjects
Detailed Description:
This will be a single-center 2-part open-label randomized Part 1 only 2-treatment study in healthy adult males n 18 Within no more than 28 days Day -28 prior to the start of Part 1 or Part 2 subjects will undergo routine screening procedures including physical examination 12-lead electrocardiograms ECGs vital signs clinical laboratory safety tests serum chemistry hematology and urinalysis serology screen fasting glucose levels including HbA1C and drug and alcohol screen
In Part 1 subjects n 6 will receive Treatment A Cohort 1 under fasted conditions Treatment A A single 20-mg oral dose of CC-223 capsule containing a microtracer of 14C- CC-223 solution For Part 1 subjects will be domiciled at the study center from Day -1 until the morning of Day 8 Upon satisfactory safety review and completion of study-related procedures subjects will be discharged from the study center on the morning of Day 8
Part 2 will be a 2-period crossover study in Period 1 subjects n 12 will be randomized to receive an oral 20 mg dose of CC-223 Treatment B under fed n 6 or fasted n 6 conditions In Period 2 subjects will receive Treatment B under converse conditions based on treatment assignment in Period 1 Cohort 2 or 3 Fed subjects will be served a standard high fat meal breakfast or its equivalent and must be consumed within 30 minutes of serving Dosing must occur 30 minutes 5 minutes after serving a subject breakfast All subjects will remain fasted until 4 hours post dose Subjects will be domiciled at the study center from Day -1 until the morning of Day 5 of each period Subjects will be discharged from the study center on the morning of Day 5 upon satisfactory safety review and completion of study-related procedures Periods 1 and 2 will be separated by a washout period of at least 7 days no more than 10 days from prior dose to the next dose In certain instances a longer washout may be acceptable if previously agreed to by the principal investigator PI and Celgene
All subjects will return to the clinic within 7 to 10 days after the day of discharge in Part 1 or Period 2 of Part 2 for follow-up safety assessments
In Part 1 subjects n 6 will receive Treatment A Cohort 1 under fasted conditions Treatment A A single 20-mg oral dose of CC-223 capsule containing a microtracer of 14C- CC-223 solution For Part 1 subjects will be domiciled at the study center from Day -1 until the morning of Day 8 Upon satisfactory safety review and completion of study-related procedures subjects will be discharged from the study center on the morning of Day 8
Part 2 will be a 2-period crossover study in Period 1 subjects n 12 will be randomized to receive an oral 20 mg dose of CC-223 Treatment B under fed n 6 or fasted n 6 conditions In Period 2 subjects will receive Treatment B under converse conditions based on treatment assignment in Period 1 Cohort 2 or 3 Fed subjects will be served a standard high fat meal breakfast or its equivalent and must be consumed within 30 minutes of serving Dosing must occur 30 minutes 5 minutes after serving a subject breakfast All subjects will remain fasted until 4 hours post dose Subjects will be domiciled at the study center from Day -1 until the morning of Day 5 of each period Subjects will be discharged from the study center on the morning of Day 5 upon satisfactory safety review and completion of study-related procedures Periods 1 and 2 will be separated by a washout period of at least 7 days no more than 10 days from prior dose to the next dose In certain instances a longer washout may be acceptable if previously agreed to by the principal investigator PI and Celgene
All subjects will return to the clinic within 7 to 10 days after the day of discharge in Part 1 or Period 2 of Part 2 for follow-up safety assessments
Study Oversight
Has Oversight DMC:
None
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?:
None