To investigate the pharmacokinetic profile of a single dose of ON 001 administered subcutaneously.To examine the safety and tolerability of a single dose of subcutaneously administered ON 001.
ID
Source
Brief title
Condition
- Bone and joint injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetics
Secondary outcome
safety and tolerability
Background summary
The research medication is a medication under development for the
rehabilitation after hipfractures.
Study objective
To investigate the pharmacokinetic profile of a single dose of ON 001
administered subcutaneously.
To examine the safety and tolerability of a single dose of subcutaneously
administered ON 001.
Study design
single centre, single dose, open label, phase 1
Intervention
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 medication and
on several time points blood will be taken and urine will be collected. The
subjects will be asked for possible side effects on a regular basis.
Furthermore several safety assessments will be done frequently.
Finally a follow up vist will take place and an end of study phone call.
Study burden and risks
ON 001 has not previously been tested in humans. Nevertheless, both components
of the research medication are commercially available and both are generally
well tolerated, in doses higher than in the present study. Studies have shown
that Vitamine B3 is well tolerated in doses up to 600.000 IU and studies using
doses of 50 mg of Nandrolone decanoate have also shown that this dose was
generally well tolerated.
The dose has been selected on a level, where risks are considered to be
minimal, but unforeseeable side effects could occur. The most important side
effects in studies where 50 mg Nandrolone decanoate was administered is were
hoarseness and weakness of the voice.
The blood collection may cause discomfort or bruising. Occasionally, fainting,
an infection at the blood sampling site, bleeding and blood clot formation can
occur.
Jansbuitensingel 7
Arnhem 6811 AA
NL
Jansbuitensingel 7
Arnhem 6811 AA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000977-21-NL |
| CCMO | NL41852.056.12 |