A Phase 1 interventional study of AG881 in Healthy Volunteers, sponsored by Agios Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-02.
Sponsored by Agios Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
The purpose of this study is to compare the pharmacokinetics (PK) and safety of AG-881 in healthy Japanese and Non-Asian participants after single oral doses of 10 mg and 50 mg of AG-881.
Agios Pharmaceuticals, Inc. is the lead sponsor of 52 studies on the registry; 6 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 4 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive AG-881 10 mg, tablet orally, once in Period 1 followed by AG-881 50 mg, tablet orally, once in Period 2. Period 1 and Period 2 will be separated by a washout period of 20 days between doses.
Drug: AG881
AG-881 tablets.
Also known as: Vorasidenib, AGI 23088, AGI 0023088
Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC0-last) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Clearance Following Extravascular Dosing (CL/F) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Plasma Concentration Observed (Cmax) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Terminal Elimination Half-life (t1/2) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time of Maximum Plasma Concentration (tmax) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution (Vd/F) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Number of Participants with Changes in Clinical Laboratory Tests from Screening to 22 days in Period 1 and 2
Clinical laboratory assessments will include hematology, blood chemistry, and urinalysis.
Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Physical Examinations from Screening to 22 days in Period 1 and 2
Physical examination will include, examination of skin, neurological, respiratory, cardiovascular, and gastrointestinal systems.
Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Vital Sign Measurements from Screening to 22 days in Period 1 and 2
Vital sign measurements will include body temperature, respiratory rate, blood pressure, and heart rate.
Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Electrocardiograms (ECGs) from Screening to 22 days in Period 1 and 2
Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence associated with the use of a drug, whether or not considered drug-related.
Time frame: Up to 28 days after last dose of AG-881 (Up to 71 days)
Number of Participants Using Concomitant Medications
Time frame: Up to 28 days after last dose of AG-881 (Up to 71 days)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Agios Pharmaceuticals, Inc.