A Study to Evaluate the Metabolism and Excretion of [14C]-CC-90009 in Healthy Male Subjects
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|ClinicalTrials.gov Identifier: NCT04297124|
Recruitment Status : Not yet recruiting
First Posted : March 5, 2020
Last Update Posted : March 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteer||Drug: CC-90009 Radiation: [14C]||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Single-Center, Open-Label Study, to Evaluate the Metabolism and Excretion of [14C]-CC-90009 in Healthy Male Subjects|
|Estimated Study Start Date :||March 18, 2020|
|Estimated Primary Completion Date :||April 24, 2020|
|Estimated Study Completion Date :||April 24, 2020|
A single IV dose of 0.6 mg [14C]-CC-90009 containing approximately 2 µCi of radioactivity will be administered on Day 1 under fasted conditions.
0.6 mg [ 14C]-CC-90009 administered IV as a single dose
A single dose of [ 14C]-CC-90009 will contain approximately 2 µCi of radioactivity.
- Pharmacokinetics - Total [14C]- radioactivity (RA) [ Time Frame: pre-dose to 240 hours post-dose ]Total [14C]-RA in whole blood, plasma, urine, and feces will be measured via LC-AMS
- Pharmacokinetics - Cumulative excretion of total [14C]-RA [ Time Frame: pre-dose to 240 hours post-dose ]Total RA recovery will be computed as the sum of the cumulative excretion (as % dose) in urine and feces.
- Pharmacokinetics - Total [14C]-RA whole blood-to-plasma ratios [ Time Frame: pre-dose to 120 hours post-dose ]Ratio of total RA recovery in whole blood compared to in plasma
- Pharmacokinetics - Cmax [ Time Frame: pre-dose to 240 hours post-dose ]Observed maximum concentration
- Pharmacokinetics - AUC [ Time Frame: pre-dose to 240 hours post-dose ]Area under the concentration
- Pharmacokinetics - Tmax [ Time Frame: pre-dose to 240 hours post-dose ]Time to Cmax.
- Pharmacokinetics - t1/2 [ Time Frame: pre-dose to 240 hours post-dose ]Terminal elimination half-life
- Adverse Events (AEs) [ Time Frame: From the time of informed consent until 28 days after the last dose of study drug. ]An 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, 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.
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): NCT04297124
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|United States, Wisconsin|
|Covance Clinical Research Unit Inc.|
|Madison, Wisconsin, United States, 53704|
|Study Director:||Kofi Mensah, MD PhD||Bristol-Myers Squibb|