Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120
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|ClinicalTrials.gov Identifier: NCT02489513|
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : December 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: [14C]-AG-120||Phase 1|
This will be a single-center, open-label, study in healthy adult males. Each subject will participate in a screening phase, a baseline phase, a treatment phase, and a follow up period. Subjects who have met all inclusion criteria and none of the exclusion criteria at screening will return to the clinical site on Day -1 for baseline assessments. Following a 10 hour overnight fast, subjects will receive a single 500mg dose of AG-120 suspension containing a microtracer of [14C] AG-120 (~ 200 μCi) under fasted conditions. The study drug will be administered as an oral suspension with approximately 240 mL of room temperature, non-carbonated water.
Blood, urine, and fecal samples (and vomitus, if applicable) will be collected throughout the study for pharmacokinetic (PK), mass balance, and/or clinical laboratory assessments. Safety will be monitored throughout the study. Subjects will be discharged from the clinical site from Day 22 to Day 29, depending on the recovery of eliminated radioactivity.
Urine and fecal samples will be collected each day until Day 29 (or the point of discharge if earlier) for measurement of total [14C] radioactivity. Blood samples for radioanalysis and PK assessment, inclusive of metabolite profiling/characterization, will be collected at pre-dose and at specified intervals through Day 29. Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomitus, if applicable ) will be determined.
Up to 8 subjects will enroll in the study. One to two additional subjects who have been confirmed as having poor metabolizer (PM) CYP2D6 genotype may be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120 Following Single Oral Dose Administration in Healthy Male Subjects|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||October 2015|
Single group assignment
Labeled investigational drug
- Pharmacokinetics - Total [14C] Whole blood and plasma [ Time Frame: up to 29 days ]Total [14C]-radioactivity in whole blood and plasmafollowing oral administration of a single 500-mg (approximately 200 μCi) radiolabeled dose of AG-120 in male subjects
- Pharmacokinetics of single dose of AG-120 (Cmax) [ Time Frame: up to 29 days ]time of maximum observed drug concentration
- Pharmacokinetics of single dose of AG-120 (AUC) [ Time Frame: up to 29 days ]Area under the curve
- Pharmacokinetics of single dose of AG-120 (t1/2) [ Time Frame: up to 29 days ]Estimate of the terminal elimination half-life
- Pharmacokinetics - Total [14C] urine and feces [ Time Frame: up to 29 days ]Total [14C]-radioactivity in urine, and feces (and vomitus, if applicable).
- AG120 Metabolite identification [ Time Frame: up to 29 days ]Blood, urine, and fecal sample analysis to identify metabolites of AG-120
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): NCT02489513
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53704|
|Study Chair:||Samuel Agresta, MD, MPH||Agios Pharmaceuticals, Inc.|