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A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Subjects With Sickle Cell Disease

NCT04536792•Agios Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of the study is to assess the safety and tolerability of AG-946 in healthy volunteers after oral administration of single ascending doses (SAD) and multiple ascending doses (MAD) of AG-946 over 14 or up to 28 days of dosing, and to identify a range of doses that are safe and pharmacologically active in participants with sickle cell disease. The SAD and MAD parts of the study will be randomized and double-blinded, and will assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of AG-946 as well as the effect of food (SAD only) on the pharmacokinetics (PK) of AG-946. The sickle cell disease (SCD) part of the study will be non-randomized and open-label, and is designed to identify 1 or more safe and tolerable dose(s) of AG-946 with potential activity in the treatment of participants with sickle cell disease (SCD).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•SAD and MAD
•Participant is a healthy male or a female of nonchildbearing potential aged 18 to 55 years inclusive at the time of consent;
•Participant is able to understand and provide informed consent before the conduct of any protocol-specific screening procedures;
•Participant is willing and able to complete all study assessments and procedures;
•Participant has a bodyweight ≥50 kilograms (kg) and body mass index ≥18.5 and ≤32 kilograms per square meter (kg/m\^2) at screening;
•Participant is in good general health with no clinically significant deviations from normal in screening medical history, physical examination, vital signs, or electrocardiogram (ECGs);
•Male participants must agree to be abstinent as part of their usual lifestyle or use contraception up to 90 days after last dose of study treatment;
•Participant is a non-smoker and has not used nicotine-containing products for at least 3 months prior to screening;
•Participant is willing to refrain from caffeine- or xanthene-containing products (eg, coffee, tea, cola, chocolate) for 48 hours before the first dose of study treatment through 7 days after the last dose of study treatment;
•Participant is willing to refrain from marijuana- or cannabinol-containing products for 7 days before admission through the final visit;
+14 more criteria

Exclusion Criteria

•SAD and MAD
•Participant has previously enrolled in this study or has received an investigational drug with 3 months or 5 half-lives of the drug, whichever is longer, before the first dose of study treatment;
•Participant has previously received AG-946, except for participants who are dosing in the fed portion of the food-effect group;
•Participant has a heart rate-corrected QT interval (QTc) interval using Fridericia correction method (QTcF) \>450 milliseconds (ms) at screening;
•Participant has used over-the-counter medication (excluding routine vitamins) within 7 days of the first dose of study treatment, unless agreed as not clinically relevant;
•Participant has used acetaminophen greater than 2 grams (g) in any 24-hour period up to 48 hours before the first dose of study treatment;
•Participants has clinically relevant screening laboratory tests results outside the normal range;
•Participant has a history of any relevant cardiovascular, renal, hepatic, chronic respiratory, or gastrointestinal disease; or hematologic, lymphatic, neurologic, endocrine, psychiatric, musculoskeletal, genitourinary, immunologic, dermatologic, or connective tissue disease or disorders;
•Participant has a history of serious mental illness, that includes, but is not limited to schizophrenia, bipolar disorder, or major depression;
•Participant has a history of any primary malignancy, except for basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies that have been curatively treated and with no evidence of disease for at least 5 years before screening;
+46 more criteria

Locations (10)

University of California San Diego

La Jolla, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

PPD Development, LP

Austin, Texas, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR

Dallas, Texas, United States

University of Texas Health Science Center of Houston

Houston, Texas, United States

Rigshospitalet, Department of Hematology

Copenhagen, Denmark

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Key Dates

Start Date

July 10, 2020

Primary Completion Date

December 19, 2023

Completion Date

December 19, 2023

Last Updated

April 16, 2024

Enrollment

122

ACTUAL participants

Conditions

Healthy VolunteersAnemia, Sickle Cell

Interventions

AG-946

DRUG

AG-946 Matched Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease

Inclusion Criteria

Exclusion Criteria

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