Oxandrolone in Healthy Adults: A Relative Bioavailability Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pharmacokinetics of a Medium Chain Triglyceride Oil Oxandrolone Solution vs. Tablets in Healthy Adults: A Relative Bioavailability Study

Conditions
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Bioavailability

Intervention / Treatment
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* Drug: Oxandrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Age 18 to 35 years (inclusive) at the time of screening Body mass index [BMI, body weight (kg)/height (m)2] below 30 kg/m2 Medically healthy Exclusion Criteria: Known allergy to anabolic steroids Use of any prescription medication currently or within 14 days prior to dosing Use of tobacco or nicotine containing products (including smoking cessation products), within 6 months prior to dosing Any chronic medical condition Seated blood pressure <90/40 mmHg or >140/90 mmHg at screening Heart rate <40 or >99 at screening Subjects who have taken any investigational drug within 30 days prior to first dose in the current study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Male Age 18 to 35 years (inclusive) at the time of screening Body mass index [BMI, body weight (kg)/height (m)2] below 30 kg/m2 Medically healthy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oxandrin<br>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. | Drug: Oxandrin<br>* The primary outcome for this study will be measurements of the pharmacokinetics of a single dose of oxandrolone 0.1 mg/kg both in tablet form and in the MCT oil preparation. Blood samples for pharmacokinetics will be drawn at 9 timepoints. Safety will be assessed by recording adverse events and assessment of hepatic function at baseline and one week following oxandrolone dosing.<br>* Other names: Oxandrolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) curve | The primary outcome for this study will be the pharmacokinetics of a single dose of oxandrolone 0.1 mg/kg both in tablet form and in the MCT oil preparation as measured by peak plasma concentration (Cmax) curve | Measurement of Peak Plasma Concentration (Cmax) at 15 min, 30 min, 1, 2, 3, 4, 8, 24, 48 hours on Days 1 and 8 | 
| Area under the plasma concentration versus time curve (AUC) | The primary outcome for this study will be the pharmacokinetics of a single dose of oxandrolone 0.1 mg/kg both in tablet form and in the MCT oil preparation as measured by the area under the plasma concentration versus time curve (AUC). | Measurements at 15 min, 30 min, 1, 2, 3, 4, 8, 24, 48 hours on Days 1 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be assessed by recording adverse events and assessment of hepatic function at baseline and one week following oxandrolone dosing. | The risks associated with the 2 doses of oxandrolone given during the course of this study are minimal. Known adverse effects of anabolic steroids, including hepatic dysfunction and virilization, are typically associated with longer-term use (months of daily dosing) and are very unlikely to occur in this study. | Liver function will be assessed by measuring serum transaminase levels at baseline and 1 week after each oxandrolone dose in the study participants, and any adverse events throughout the study period and up to 1 week after final dosing will be recorded. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxandrolone, cardiac