An open-label, phase 1 study in healthy elderly females to investigate the pharmacokinetic profile of a fixed combination of 25 mg nandrolone decanoate and 14.000 IU vitamin D3 (ON 001) administered subcutaneously.
- Conditions
- Recovery from hip fractures10005942
- Registration Number
- NL-OMON37203
- Lead Sponsor
- OrgaNext Research B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
- Caucasian females with a minimum age of 65 years and a maximum age of 80 years and a BMI between 20 and 30 kg/m2.;- Good physical and mental health. No clinical relevant findings as determined by the Principal Invesigator based on the past medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory test results at screening and baseline.;- Subjects* clinical laboratory tests must be within normal limits or clinically acceptable to the investigator at screening. ;- The 12-lead ECG conduction intervals must be within female-specific normal range (QTcB <= 450 msec, PR interval <= 200 msec).;Refer to protocol for a complete list of inclusion criteria
- Treatment with another investigational drug within 4 months prior to dosing.;- Donation or loss of 500 mL or more of blood within 90 days prior to administration of the study medication.;- Positive urine drug screen or alcohol breath test.;- Serology positive for hepatitis B, hepatitis C, or HIV antibodies.;- History of sensitivity to nandrolone decanoate, vitamin D3 or chemically related compounds or excipients.;Refer to protocol for a complete list of exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics</p><br>
- Secondary Outcome Measures
Name Time Method <p>safety and tolerability</p><br>