Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-02-02 @ 4:12 AM
Study NCT ID:
NCT02149966
Status:
COMPLETED
Last Update Posted:
2014-11-10
First Post:
2014-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of AG-348 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634504', 'term': 'mitapivat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-07', 'studyFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '29 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics parameters of AG-348', 'timeFrame': '17 days', 'description': 'Descriptive statistics will be used to summarize PK parameters of AG-348 for each dose group and, where appropriate, for the entire population. Standard non-compartmental PK parameters will be calculated from individual plasma concentration data.'}, {'measure': 'Pharmacodynamic (PD) relationship of AG-348 and metabolic biomarkers', 'timeFrame': '17 days', 'description': 'The potential relationship between AG-348 and metabolic biomarkers will be explored with descriptive and graphical methods. Details on the evaluation of pyruvate kinase (PKR) activity and other potential PD biomarkers will be described.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety and tolerability', 'pharmacokinetic study'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'references': [{'pmid': '30091852', 'type': 'DERIVED', 'citation': 'Yang H, Merica E, Chen Y, Cohen M, Goldwater R, Kosinski PA, Kung C, Yuan ZJ, Silverman L, Goldwasser M, Silver BA, Agresta S, Barbier AJ. Phase 1 Single- and Multiple-Ascending-Dose Randomized Studies of the Safety, Pharmacokinetics, and Pharmacodynamics of AG-348, a First-in-Class Allosteric Activator of Pyruvate Kinase R, in Healthy Volunteers. Clin Pharmacol Drug Dev. 2019 Feb;8(2):246-259. doi: 10.1002/cpdd.604. Epub 2018 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending (increasingly higher) oral doses of AG-348 daily for 14 days to evaluate the safety and tolerability of multiple oral doses of AG-348, the pharmacokinetics (PK) of multiple doses of AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult male or female subjects 18 - 60 years, in good general health who are able to understand consent and complete all study procedures.\n* Female subjects of non-child bearing potential (surgically sterile or post-menopausal as confirmed by age \\[over 50 years\\], amenorrhea for ≥12 consecutive months and FSH).\n* Male subjects who are not vasectomized must agree to use contraception up to 30 days after dosing.\n* Subjects with body weight ≥50 kg; BMI ≥18.5 and ≤32 kg/m2.\n* Subjects who are non-smokers and have not used nicotine-containing products for at least 3 months prior to screening.\n* Subjects must be willing to refrain from caffeine- or xanthene-containing products (coffee, tea, chocolate) for 48 hours prior to dosing through discharge from the clinical facility.\n* Subjects must agree to refrain from strenuous exercise starting 72 hours prior to admission through final follow-up visit.\n* Subjects must refrain from use of alcohol starting 7 days (14 days for red wine) prior to admission through final follow-up visit.\n* Subjects must agree not to donate blood products for duration of study participation.\n\nExclusion Criteria:\n\n* Subjects who have previously received AG-348.\n* Subjects with clinically relevant screening laboratory tests.\n* Female subjects who are not post-menopausal.\n* Subjects with recent use of prescription, over the counter (OTC), herbal and/or dietary medications and/or supplements.\n* Male subjects with QTcF interval ECG \\> 450 msec,or female subjects with QTcF interval ECG \\> 470 msec.\n* Subjects with a history of a serious mental illness.\n* Subjects with a clinically relevant medical history or pre-existing medical condition that would interfere with the absorption, metabolism or excretion of the study drug.\n* Subjects with a history of any primary malignancy (cancer). Exceptions are certain skin cancers, cervical cancer in situ or other cancers that have been curatively treated without evidence of disease for a minimum of 1 year.\n* Subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.\n* Subjects who are positive for hepatitis B, hepatitis C or HIV.\n* Subjects who have undergone surgery 6 months prior to screening.\n* Subjects who have a history of illicit drug use or alcoholism within the last year.\n* Subjects who are participating in other concurrent clinical trial of an investigational drug, or have received another investigational agent within the last 2 months.\n* Subjects with any conditions which would make the subject unsuitable for enrollment, or could interfere with the subject's participation in or completion of the study."}, 'identificationModule': {'nctId': 'NCT02149966', 'acronym': 'AG-348MAD', 'briefTitle': 'A Phase I Study of AG-348 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Agios Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Pharmacokinetic, and Pharmacodynamic Study of Orally Administered AG-348 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'AG348-C-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AG-348', 'description': 'Multiple oral doses of AG-348', 'interventionNames': ['Drug: AG-348']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Multiple oral doses of placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AG-348', 'type': 'DRUG', 'description': 'A range of doses of AG-348 will be tested based on the assessment of safety and tolerability. AG-348 will be administered by mouth (orally) each day for a period of 14 days.', 'armGroupLabels': ['AG-348']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered by mouth (orally) each day for a period of 14 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Samuel Agresta, MD, MPH & TM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Agios Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agios Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}