NL-OMON37203
Completed
Not Applicable
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. - ON 001.01
OrgaNext Research B.V.0 sites14 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recovery from hip fractures
- Sponsor
- OrgaNext Research B.V.
- Enrollment
- 14
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion 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
Outcomes
Primary Outcomes
Not specified
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