Oxandrolone in Healthy Adults: A Relative Bioavailability Study

Bioavailability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218631
• Other study ID #: 99086
• Status: Completed
• Phase: Phase 1
• Start date: July 10, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: May 2018
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• Oxandrin
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.

Locations

Country	Name	City	State
United States	Primary Children's Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.