A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CC-99677 in Healthy Adult Subjects
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|ClinicalTrials.gov Identifier: NCT03554993|
Recruitment Status : Completed
First Posted : June 13, 2018
Last Update Posted : February 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteer||Drug: CC-99677 Other: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||May 23, 2018|
|Actual Primary Completion Date :||July 3, 2019|
|Actual Study Completion Date :||July 3, 2019|
Experimental: CC-99677 Under Fasted Conditions
CC-99677 Under Fasted Conditions
Placebo under fasted conditions
Experimental: CC-99677 Under Fed Conditions
CC-99677 Under Fed Conditions
- Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of treatment ]Number of subjects with adverse events
- Pharmacokinetics - Cmax [ Time Frame: up to 28 days ]Maximum observed plasma concentration
- Pharmacokinetics - Tmax [ Time Frame: up to 28 days ]Time to Cmax
- Pharmacokinetics - AUC0-∞ [ Time Frame: up to 28 days ]Area under the plasma concentration-time curve from time zero extrapolated to infinity
- Pharmacokinetics - AUC0-t [ Time Frame: up to 28 days ]Area under the plasma concentration-time curve from time zero extrapolated to the last quantifiable concentration
- Pharmacokinetics - t1/2,z [ Time Frame: up to 28 days ]Terminal elimination half-life
- Pharmacokinetics - CL/F [ Time Frame: up to 28 days ]Apparent total clearance
- Pharmacokinetics - Vz/F [ Time Frame: up to 28 days ]Apparent total volume of distribution
- Effect of CC-99677 on electrocardiogram (ECG) parameters [ Time Frame: up to 24 hours after single dose administration ]ECG data will be collected using continuous 12 lead digital Holter recorders at prespecified timepoints
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554993
|Ruddington, United Kingdom, NG11 6JS|
|Study Director:||Francisco Ramirez-Valle, MD, PhD||Celgene|