Bioavailability
Conditions
Keywords
oxandrolone, cardiac
Brief summary
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
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.
Interventions
DRUGOxandrin
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.
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety will be assessed by recording adverse events and assessment of hepatic function at baseline and one week following oxandrolone dosing. | 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. | 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. |
Countries
United States
Outcome results
None listed