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Oxandrolone in Healthy Adults: A Relative Bioavailability Study

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxandrolone

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218631


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

Responsible Party: Phillip Burch, MD, University of Utah
ClinicalTrials.gov Identifier: NCT03218631     History of Changes
Other Study ID Numbers: 99086
First Posted: July 14, 2017    Key Record Dates
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