Oxandrolone in Healthy Adults: A Relative Bioavailability Study

• ClinicalTrials.gov Identifier: NCT03218631
• Recruitment Status: Completed
• First Posted: July 14, 2017
• Last Update Posted: May 3, 2018
• Sponsor: University of Utah
• Information provided by (Responsible Party): Phillip Burch, University of Utah

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bioavailability	Drug: Oxandrin	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment

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

• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics of a Medium Chain Triglyceride Oil Oxandrolone Solution vs. Tablets in Healthy Adults: A Relative Bioavailability Study
• Actual Study Start Date: July 10, 2017
• Actual Primary Completion Date: November 30, 2017
• Actual Study Completion Date: November 30, 2017

Arms and Interventions

Arm

Intervention/treatment

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 Name: Oxandrolone

Outcome Measures

Primary Outcome Measures :

1. Peak Plasma Concentration (Cmax) curve [ Time Frame: 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
2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 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 Outcome Measures :

1. Safety will be assessed by recording adverse events and assessment of hepatic function at baseline and one week following oxandrolone dosing. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Only male subjects will be included to avoid the possibility of a pregnant female inadvertently receiving the study drug and to eliminate any cofounders related to gender. Oxandrolone is contraindicated in pregnancy. Subjects will be enrolled without regard to race and ethnicity.
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Utah

Primary Children's Hospital

Salt Lake City, Utah, United States, 84113

Sponsors and Collaborators

University of Utah

Investigators

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

More Information

• Responsible Party: Phillip Burch, MD, University of Utah
• ClinicalTrials.gov Identifier: NCT03218631
• Other Study ID Numbers: 99086
• First Posted: July 14, 2017
• Last Update Posted: May 3, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Individual Patient data will only be shared with the research team

• 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

Keywords provided by Phillip Burch, University of Utah:

oxandrolone, cardiac

Additional relevant MeSH terms:

Oxandrolone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anabolic Agents