Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT03554993
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2018-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CC-99677 in Healthy Adult Subjects
Sponsor:
Celgene
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Single-center, 3-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of CC 99677 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2020-02
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 is a phase 1, randomized, single-center, 3-part, FIH study to assess the safety, tolerability, pharmacokinetics (PK, or how the drug behaves in the body), and pharmacodynamics (PD, or what the drug does to the body) of single and multiple doses of CC-99677 and to characterize the effect of food on the single-dose PK of CC-99677 in healthy adult subjects.
Detailed Description:
This first-in-human (FIH) study aims to identify a safe and tolerable dose of CC 99677 in support of phase 2 and/or phase 3 studies to be conducted in subjects with underlying inflammatory diseases.
The study also aims to evaluate the PK of CC-99677 following administration of single and multiple oral doses, including assessment of the effect of food on the single dose PK of CC 99677, and to assess the effect of CC 99677 on electrocardiogram (ECG) parameters in healthy adult subjects. The pharmacodynamics (PD) and pharmacogenomics (PG) of CC 99677 will also be assessed.
Parts 1 and 2 are designed to evaluate the safety, tolerability, PK, and PD of single and multiple ascending doses of CC 99677, respectively. The study has been designed to allow for safety, tolerability, and PK data to be gathered in a stepwise fashion. Part 1 will consist of escalating single doses in sequential groups. Approximately 48 subjects will be enrolled into 6 planned dose level cohorts. Part 2 will consist of escalating multiple doses (administered for 14 days) in sequential groups. In Part 2, approximately 40 subjects will be enrolled into 5 proposed dose level cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive CC-99677 and 2 subjects will receive placebo according to the randomization schedule. In both Part 1 and Part 2, a higher daily dose level will not be initiated until adequate information on the preceding dose level is available and reviewed. Parts 1 and 2 will also employ strict dose escalation, individual subject, and intra cohort stopping criteria. Parts 1 and 2 will be placebo controlled to appropriately characterize the safety and tolerability of CC 99677.
Part 3 is designed to characterize the effect of food on the single dose PK of CC 99677.
The study also aims to evaluate the PK of CC-99677 following administration of single and multiple oral doses, including assessment of the effect of food on the single dose PK of CC 99677, and to assess the effect of CC 99677 on electrocardiogram (ECG) parameters in healthy adult subjects. The pharmacodynamics (PD) and pharmacogenomics (PG) of CC 99677 will also be assessed.
Parts 1 and 2 are designed to evaluate the safety, tolerability, PK, and PD of single and multiple ascending doses of CC 99677, respectively. The study has been designed to allow for safety, tolerability, and PK data to be gathered in a stepwise fashion. Part 1 will consist of escalating single doses in sequential groups. Approximately 48 subjects will be enrolled into 6 planned dose level cohorts. Part 2 will consist of escalating multiple doses (administered for 14 days) in sequential groups. In Part 2, approximately 40 subjects will be enrolled into 5 proposed dose level cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive CC-99677 and 2 subjects will receive placebo according to the randomization schedule. In both Part 1 and Part 2, a higher daily dose level will not be initiated until adequate information on the preceding dose level is available and reviewed. Parts 1 and 2 will also employ strict dose escalation, individual subject, and intra cohort stopping criteria. Parts 1 and 2 will be placebo controlled to appropriately characterize the safety and tolerability of CC 99677.
Part 3 is designed to characterize the effect of food on the single dose PK of CC 99677.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: