Oxandrolone in Healthy Adults: A Relative Bioavailability Study

NCT03218631 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 99086
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability

Keywords

oxandrolone, cardiac

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety will be assessed by recording adverse events and assessment of hepatic function at baseline and one week following oxandrolone dosing.

  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.

Study Arms (1)

Oxandrin

OTHER

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

Interventions

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.

Also known as: Oxandrolone

Oxandrin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

MeSH Terms

Interventions

Oxandrolone

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Phillip T. Burch, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: July 14, 2017
• Study Start: July 10, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)