nctId: NCT06286033 id: AG181-C-001 briefTitle: A Safety Study of Single and Multiple Doses of AG-181 in Healthy Participants overallStatus: RECRUITING date: 2024-02-20 date: 2025-06-01 date: 2025-06-01 date: 2024-02-29 date: 2024-04-16 name: Agios Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The primary purpose of this study is to assess the safety and tolerability of AG-181 in healthy participants after oral administration of single ascending dose (SAD) of AG-181 in Part 1 and multiple ascending dose (MAD) in Part 2 along with the effect of food on the pharmacokinetics (PK) of single oral doses of AG-181 in healthy participants in Part 3. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: AG-181 name: Placebo measure: SAD: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug measure: MAD: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug measure: Food Effect: Maximum Observed Plasma Concentration (Cmax) of AG-181 measure: Food Effect: Area Under the Concentration-time Curves (AUCs) of AG-181 measure: Food Effect: Time to Reach Maximum Observed Concentration (tmax) of AG-181 measure: Food Effect: Terminal Elimination Rate Constant (Kel) of AG-181 measure: Food Effect: Terminal Elimination Half-Life (t1/2) of AG-181 measure: Food Effect: Apparent Oral Clearance (CL/F) of AG-181 measure: Food Effect: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 measure: SAD: Maximum Observed Plasma Concentration (Cmax) of AG-181 measure: SAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181 measure: SAD: Terminal Elimination Rate Constant (Kel) of AG-181 measure: SAD: Terminal Elimination Half-Life (t1/2) of AG-181 measure: SAD: Area Under the Concentration-time Curves (AUCs) of AG-181 measure: SAD: Apparent Oral Clearance (CL/F) of AG-181 measure: SAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 measure: SAD: Renal Clearance (CLR) of AG-181 measure: SAD: Total Percent of AG-181 Dose Excreted Unchanged in Urine (Fet%) measure: SAD: Percent of AG-181 Dose Excreted Unchanged in Urine Between Time 1 and Time 2 (Fet1-t2%) measure: SAD: Cumulative Amount of AG-181 Drug Excreted in Urine (Ae0-t) measure: SAD: Amount of AG-181 Drug Excreted in Urine Between Time 1 and Time 2 (Aet1-t2) measure: MAD: Maximum Observed Plasma Concentration (Cmax) of AG-181 measure: MAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181 measure: MAD: Terminal Elimination Rate Constant (Kel) of AG-181 measure: MAD: Terminal Elimination Half-Life (t1/2) of AG-181 measure: MAD: Area Under the Concentration-time Curve (AUC) of AG-181 measure: MAD: Apparent Oral Clearance (CL/F) of AG-181 measure: MAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 measure: MAD: Time to Maximum Observed Plasma Concentration at Steady State (Cmax_ss) of AG-181 measure: MAD: Accumulation Ratio for Cmax (RA_Cmax) of AG-181 measure: MAD: Accumulation Ratio for Area Under the Concentration-time Curve (RA_AUC) of AG-181 measure: Food Effect: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ICON 1255 East 3900 South status: RECRUITING city: Salt Lake City state: Utah zip: 84124 country: United States lat: 40.76078 lon: -111.89105 hasResults: False