Recovery from hip fractures
Conditions
Interventions
The study will start with a screening. At the screening a physical examination
will take place and a few other standard medical assessments will be performed
( Vital Signs
ECG). Furthermore a blood and urine sample will be taken for
laboratory tests and an alcohol breath test and drug screen will be done.
During the stay in the clinic the subject will receive the study
Sponsors
OrgaNext Research B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability | — |
Countries
Netherlands
Outcome results
None listed