BioavailabilityPhase 1NCT03218631
Oxandrolone in Healthy Adults: A Relative Bioavailability Study
A Phase 1 study testing Oxandrin in people with Bioavailability, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Oxandrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2017to 30 Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Primary Children's Hospital
Salt Lake City, Utah, 84113
About this study
Official title: 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.
Read the 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.
- Conditions
- Bioavailability
- Being tested
- Oxandrin
- Keywords
- oxandrolone, cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxandrinDrug
Also called Oxandrolone
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oxandrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start10 Jul 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Burch, University of Utah
- Investigators
- Phillip T. Burch, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218631
- Sponsor's protocol ID
- 99086
- Status last verified
- May 2018
- First submitted
- 4 Apr 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Patient data will only be shared with the research team
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of a Medium Chain Triglyceride Oil Oxandrolone Solution vs. Tablets in Healthy Adults: A Relative Bioavailability Study
- ClinicalTrials.gov ID
- NCT03218631
- Acronym / sponsor ID
- 99086
- Conditions
- Bioavailability
- Keywords
- oxandrolone, cardiac
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Oxandrin | Other | Drug: OxandrinAdministration 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxandrinAlso: OxandroloneThe 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. | Drug | Oxandrin |
Primary outcome
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
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).
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: No. Individual Patient data will only be shared with the research team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip T. Burch, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxandrin in people with Bioavailability, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.