A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the Body in Healthy Participants
- Registration Number
- NCT07075640
- Lead Sponsor
- Agios Pharmaceuticals, Inc.
- Brief Summary
The primary purpose of this study is to assess the safety and tolerability of a single dose of AG-236 administered subcutaneously in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Treatment Group A AG-236 Participants will receive a single dose of AG-236 at dose level 1 or placebo on Day 1 under fasted conditions. Treatment Group A Placebo Participants will receive a single dose of AG-236 at dose level 1 or placebo on Day 1 under fasted conditions. Treatment Group B AG-236 Participants will receive a single dose of AG-236 at dose level 2 or placebo on Day 1 under fasted conditions. Treatment Group B Placebo Participants will receive a single dose of AG-236 at dose level 2 or placebo on Day 1 under fasted conditions. Treatment Group C AG-236 Participants will receive a single dose of AG-236 at dose level 3 or placebo on Day 1 under fasted conditions. Treatment Group C Placebo Participants will receive a single dose of AG-236 at dose level 3 or placebo on Day 1 under fasted conditions.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug Up to Day 57
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AG-236 Predose and multiple time points postdose from Day 1 to Day 57 Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of AG-236 Predose and multiple time points postdose from Day 1 to Day 57 Maximum Observed Plasma Concentration (Cmax) of AG-236 Predose and multiple time points postdose from Day 1 to Day 57 Percentage of Area Under the Concentration-Time Curve due to Extrapolation From the Last Quantifiable Concentration to Infinity (AUC%extrap) of AG-236 Predose and multiple time points postdose from Day 1 to Day 57 Time to Last Measurable Concentration (tlast) of AG-236 Predose and multiple time points postdose from Day 1 to Day 57 Time to Reach Maximum Observed Plasma Concentration (tmax) of AG-236 Predose and multiple time points postdose from Day 1 to Day 57 Terminal Elimination Half-Life (t1/2) of AG-236 Predose and multiple time points postdose from Day 1 to Day 57 Apparent Total Body Clearance (CL/F) of AG-236 Predose and multiple time points postdose from Day 1 to Day 57 Apparent Volume of Distribution (Vz/F) of AG-236 Predose and multiple time points postdose from Day 1 to Day 57 Amount of Unchanged AG-236 Excreted in Urine From Day 1 to Day 3 (Aet1-t2) Predose and multiple time points postdose from Day 1 to Day 3 Cumulative Amount of Unchanged AG-236 Excreted in Urine (Cum Aeu) Predose and multiple time points postdose from Day 1 to Day 3 Percentage of AG-236 Dose Excreted Unchanged in Urine From Day 1 to Day 3 (fet1-t2) Predose and multiple time points postdose from Day 1 to Day 3 Cumulative Percentage of AG-236 Dose Excreted Unchanged in Urine (Cum fe) Predose and multiple time points postdose from Day 1 to Day 3 Renal Clearance (CLR) of AG-236 Predose and multiple time points postdose from Day 1 to Day 3 Change From Baseline in Serum Hepcidin Levels Baseline, Days 2, 3, 8, 29, and 57
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit Inc.
🇺🇸Madison, Wisconsin, United States
Fortrea Clinical Research Unit Inc.🇺🇸Madison, Wisconsin, United States