To assess the pharmacokinetics and relative bioavailability of a single dose of approximately 0.1 mg/kg of a medium chain triglyceride (MCT) oil oxandrolone solution vs. tablets in a small cohort of healthy adults.

The results of this study will provide data regarding the relative bioavailability of a novel preparation of oxandrolone in MCT oil, which will allow dosing in neonates and small infants. This pilot study will provide information to design a larger multicenter study of neonates undergoing surgery for complex congenital heart disease.

Inclusion Criteria:

1. Male
2. Age 18 to 35 years (inclusive) at the time of screening
3. Body mass index [BMI, body weight (kg)/height (m)2] below 30 kg/m2
4. Medically healthy

Exclusion Criteria:

1. Known allergy to anabolic steroids
2. Use of any prescription medication currently or within 14 days prior to dosing
3. Use of tobacco or nicotine containing products (including smoking cessation products), within 6 months prior to dosing
4. Any chronic medical condition
5. Seated blood pressure <90/40 mmHg or >140/90 mmHg at screening
6. Heart rate <40 or >99 at screening
7. Subjects who have taken any investigational drug within 30 days prior to first dose in the current study

Only male subjects will be included to avoid the possibility of a pregnant female inadvertently receiving the study drug and to eliminate any cofounders related to gender. Oxandrolone is contraindicated in pregnancy. Subjects will be enrolled without regard to race and ethnicity.

Individual Patient data will only be shared with the research team