Oxandrolone in Healthy Adults: A Relative Bioavailability Study

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 1

Conditions: Bioavailability

Treatments: Drug: Oxandrin

Study type: Interventional

Funder types: Other

Identifiers

NCT03218631

99086

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Oxandrin

Other group

Description:

Administration of a single dose of approximately 0.1 mg/kg of a medium chain triglyceride (MCT) oil Oxandrin (oxandrolone) solution vs. 01.mg/kg tablets in a small cohort of healthy adults. Participants will be dosed at two time points one week apart.

Treatment:

Drug: Oxandrin