protocolSection identificationModule nctId: NCT06286033, orgStudyIdInfo id: AG181-C-001, briefTitle: A Safety Study of Single and Multiple Doses of AG-181 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Agios Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: AG-181, interventions name: Placebo, outcomesModule primaryOutcomes measure: SAD: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug, primaryOutcomes measure: MAD: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug, primaryOutcomes measure: Food Effect: Maximum Observed Plasma Concentration (Cmax) of AG-181, primaryOutcomes measure: Food Effect: Area Under the Concentration-time Curves (AUCs) of AG-181, primaryOutcomes measure: Food Effect: Time to Reach Maximum Observed Concentration (tmax) of AG-181, primaryOutcomes measure: Food Effect: Terminal Elimination Rate Constant (Kel) of AG-181, primaryOutcomes measure: Food Effect: Terminal Elimination Half-Life (t1/2) of AG-181, primaryOutcomes measure: Food Effect: Apparent Oral Clearance (CL/F) of AG-181, primaryOutcomes measure: Food Effect: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181, secondaryOutcomes measure: SAD: Maximum Observed Plasma Concentration (Cmax) of AG-181, secondaryOutcomes measure: SAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181, secondaryOutcomes measure: SAD: Terminal Elimination Rate Constant (Kel) of AG-181, secondaryOutcomes measure: SAD: Terminal Elimination Half-Life (t1/2) of AG-181, secondaryOutcomes measure: SAD: Area Under the Concentration-time Curves (AUCs) of AG-181, secondaryOutcomes measure: SAD: Apparent Oral Clearance (CL/F) of AG-181, secondaryOutcomes measure: SAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181, secondaryOutcomes measure: SAD: Renal Clearance (CLR) of AG-181, secondaryOutcomes measure: SAD: Total Percent of AG-181 Dose Excreted Unchanged in Urine (Fet%), secondaryOutcomes measure: SAD: Percent of AG-181 Dose Excreted Unchanged in Urine Between Time 1 and Time 2 (Fet1-t2%), secondaryOutcomes measure: SAD: Cumulative Amount of AG-181 Drug Excreted in Urine (Ae0-t), secondaryOutcomes measure: SAD: Amount of AG-181 Drug Excreted in Urine Between Time 1 and Time 2 (Aet1-t2), secondaryOutcomes measure: MAD: Maximum Observed Plasma Concentration (Cmax) of AG-181, secondaryOutcomes measure: MAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181, secondaryOutcomes measure: MAD: Terminal Elimination Rate Constant (Kel) of AG-181, secondaryOutcomes measure: MAD: Terminal Elimination Half-Life (t1/2) of AG-181, secondaryOutcomes measure: MAD: Area Under the Concentration-time Curve (AUC) of AG-181, secondaryOutcomes measure: MAD: Apparent Oral Clearance (CL/F) of AG-181, secondaryOutcomes measure: MAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181, secondaryOutcomes measure: MAD: Time to Maximum Observed Plasma Concentration at Steady State (Cmax_ss) of AG-181, secondaryOutcomes measure: MAD: Accumulation Ratio for Cmax (RA_Cmax) of AG-181, secondaryOutcomes measure: MAD: Accumulation Ratio for Area Under the Concentration-time Curve (RA_AUC) of AG-181, secondaryOutcomes measure: Food Effect: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: ICON 1255 East 3900 South, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84124, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False