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NCT Number: NCT03218631

Oxandrolone 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.

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Key information

Conditions

Bioavailability

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxandrin

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2017
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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