Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects

Inclusion Criteria:

- Applicable to Japanese Subjects Only: Japanese subjects must have been born in Japan,
have both parents and grandparents of Japanese origin, and not have lived outside of
Japan for more than 5 years.

- Applicable to Caucasian Subjects Only: Non-Japanese subjects must be Caucasian (ie,
White) but may be of any ethnicity.

- Healthy male subjects between 18 and 55 years of age (inclusive).

- Provision of voluntary, written informed consent.

- Capable of adhering to trial restrictions and examination schedules, in the opinion of
the Investigator.

- Must be able to communicate with the Investigator.

- Must be in good health as determined by the Investigator according to past medical
history, physical examination, vital signs, clinical laboratory test results, and
ECGs.

- Must have a body mass index (BMI) between 18 and 29 kg/m2 (inclusive), and body weight
between 50-120kg.

- Clinical laboratory test results (serum chemistry, hematology, and urinalysis) must be
within normal limits or considered by the Investigator to be not clinically
significant after confirmation with the Agios Medical Monitor.

- Vital signs (systolic and diastolic blood pressure, pulse rate, and oral body
temperature) will be assessed in the supine position after the subject has rested for
at least 5 minutes. Subject must be afebrile with vital signs within the following
ranges at screening, Day -1 and pre dose: Systolic blood pressure: 90 to 140 mmHg;
Diastolic blood pressure: 50 to 90 mmHg; Pulse rate: 40 to 110 bpm

- Must have a normal or clinically acceptable 12-lead ECG no later than Day -1. Subjects
must have a pre-dose QT interval corrected for heart rate using Fridericia's formula
(QTcF) value or average of 3 values, ≤450 msec. An ECG may be repeated once to
determine subject eligibility after confirmation with the Agios Medical Monitor.

- Subjects (with or without vasectomy) must agree to abstain from sexual intercourse or
agree to the use of highly effective contraceptive methods (at screening and
throughout the course of the trial) and should avoid fathering a child during the
course of the trial and for 90 days following the dose of the IMP. Subjects must
refrain from sperm donations for the entire duration of the trial and for 90 days
following the dose of AG 120.

Exclusion Criteria:

- Any significant medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from providing informed consent or participating in the
trial in the opinion of the Investigator.

- Any condition, including the presence of laboratory abnormalities, which places the
subject at an unacceptable risk if he were to participate in the trial.

- Recent history (within 3 years prior to dosing) of any clinically significant
neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological,
pulmonary, metabolic, endocrine, hematological, or other major disorder.

- Use of any prescribed systemic or topical medication within 30 days or 5 terminal
half-lives, whichever is longer, of IMP administration.

- Exposure to an investigational drug within 30 days prior to IMP administration or 5
half lives of that investigational drug, if known (whichever is longer).

- Use of any non-prescribed systemic or topical medication (including vitamin/mineral
supplements, and herbal medicines, eg, St. John's Wort) within 7 days of IMP
administration.

- Any surgical or medical condition that could affect drug absorption, distribution,
metabolism, or excretion (eg, gastrectomy and cholecystectomy)

- Subjects who plan to have any elective or medical procedures during the conduct of the
trial (eg, dental procedure).

- History of clinically significant multiple drug allergies (ie, 2 or more).

- Any clinically significant allergic disease.

- History of drug abuse (as defined by the current version of the Diagnostic and
Statistical Manual [DSM]) within 2 years prior to IMP administration, or positive drug
screen test due to illicit drugs at any time prior to IMP administration during the
screening period.

- History of alcohol abuse within 2 years prior to IMP administration, or positive
alcohol screen at any time prior to IMP administration during the screening period.

- History of smoking within 3 months prior to IMP administration, or positive urine
cotinine screen at any time prior to IMP administration during the screening period.

- Known to have human immunodeficiency virus (HIV), hepatitis, or known to be a carrier
of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have
positive results at screening.