A Bioavailability Study of MIV-711 Oral Formulations in Healthy Volunteers

Inclusion Criteria (subset):

- Healthy, adult, male or female, 19-55 years of age, inclusive, at screening.

- Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at screening.

- Medically healthy with no clinically significant medical history, physical
examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or
designee.

- If not a menopausal female or surgically sterile male or female, subjects must be
willing to practice at least one of the in the CSP described highly effective methods
of birth control for at least a (partner's) menstrual cycle before and for 3 months
after study drug administration.

- For a female of non-childbearing potential: must have undergone one of the following
sterilization procedures at least 6 months prior to the first dose:

- hysteroscopic sterilization;

- bilateral tubal ligation or bilateral salpingectomy;

- hysterectomy;

- bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 2 years
prior to the first dose and follicle-stimulating hormone (FSH) serum levels
consistent with postmenopausal status as per PI or designee judgment.

Exclusion Criteria (subset):

- History or presence of clinically significant medical or psychiatric condition or
disease in the opinion of the PI or designee.

- History of any illness that, in the opinion of the PI or designee, that could affect
the action, absorption, or disposition of MIV-711 or may confound the results of the
study or poses an additional risk to the subject by their participation in the study.

- History or presence of known structural cardiac abnormalities, syncope, cardiac
conduction problems (first, second, or third degree heart blocks, bundle branch block,
or incomplete block, atrial fibrillation and/or paroxysmal atrial fibrillation, sick
sinus syndrome or prolonged QTc interval), inappropriate sinus bradycardia, deviant
ECG morphology or exercise related cardiac events.

- Unable to refrain from or anticipates the use of:

- Any drug, including prescription and non-prescription medications, herbal
remedies, or vitamin supplements beginning 14 days prior to the first dose and
throughout the study. Medication listed as part of acceptable birth control
methods will be allowed.

- Any drugs known to be inducers of CYP enzymes for 28 days prior to the first dose
of study drug and throughout the study. Appropriate sources will be consulted by
the PI or designee to confirm lack of PK/PD interaction with study drug.

- Acetaminophen (up to 2 g per 24 hour period) may be permitted during the study.

- Hormone replacement therapy will also be allowed.

- Subjects on a stable dose (at least 3 months) of thyroid medication will be
allowed.

- An inability to follow a standardized diet and meal schedule or inability to fast, as
required during the study.