Oxandrolone in Healthy Adults: A Relative Bioavailability Study

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

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.

Study Overview

• Status: Completed
• Conditions: Bioavailability
• Intervention / Treatment: Drug: Oxandrin

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Oxandrin; 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; 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.; Other Names: Oxandrolone

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Phillip T. Burch, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: oxandrolone, cardiac
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Anabolic Agents; Oxandrolone
• Other Study ID Numbers: 99086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual Patient data will only be shared with the research team

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No