T\o evaluate the pharmacokinetics, safety and tolerability of the research medication
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetics, safety and tolerability in healthy volunteers
Secondary outcome
- Relative bioavailability of subcutaneously versus intravenously
administration of the study drug
- Pharmacokinetics, safety and tolerability in subjects with CLBP
Background summary
The research medication is a new medication under development for treatment of
Chronic Low Back Pain (CLBP).
Study objective
T\o evaluate the pharmacokinetics, safety and tolerability of the research
medication
Study design
This is a Phase 1, single center, open-label, randomized, parallel-group study
Intervention
The study will start with a screening. At the screening a physical-, and
neurological examination will take place and a few other standard medical
assessments will be performed ( Vital Signs, ECG). Also a standard brief
assessment of cognitive impairment (MMSE) will be performed. Furthermore a
blood and urine sample will be taken for laboratory tests and an alcohol breath
test and drug screen will be done.
For the CLBP group an x-ray will be performed and the subject's CLBP intensity
will be assessed.
During the stay in the clinic the subject will receive the study medication and
on several time points blood will be taken. Furthermore, a neurological
examination will be performed as well as a standard brief assessment of
cognitive impairment (MMSE). The subjects will be asked for possible side
effects on a regular basis. Furthermore a drug screen will be performed and
several safety assessments will be done frequently. For the CLBP group the
subject's CLBP intensity will be assessed.
On ambulant visits blood will be collected, safety assessments will be done and
CLBP intensity will be assessed for the CLBP group. Safety assessments will be
done frequently.
Finally, a follow up visit will take place.
Study burden and risks
The safety and pharmacokinetics of ABT-110 has been investigated in one study
in humans, administered intravenously (IV) to subjects with osteoarthritis (OA)
of the knee. In that study, the dose was generally well-tolerated. Since the
maximum administered dose in the present study is based on the ABT-110
first-in-human study it is expected that the research medication will be
well-tolerated in the present study as well.
Side effects reported in the first ABT-110 study were headache, arthralgia,
pain in extremity, myalgia, paraesthesia, nasopharyngitis, hyperaesthesia,
hypoaesthesia, joint stiffness, joint swelling, dizziness, infusion related
reaction, restless legs syndrome, fatigue, back pain,
burning sensation, hot flashes, nausea, osteoarthritis and oedema peripheral.
The maximum dose has been selected on a level, where risks for side effects are
considered to be minimal, but unforseeable side effects could occur.
The blood collection may cause discomfort or bruising. Occasionally, fainting,
an infection at the blood smpling site, bleeding and blood clot formation can
occur.
Abbott Park Road 100
Abbott Park 60064
US
Abbott Park Road 100
Abbott Park 60064
US
Listed location countries
Age
Inclusion criteria
Healthy Volunteers: Male or female aged 18-55 years; females must be postmenopausal or surgically sterilized; BMI between 18 and 29 inclusive; general good health.
CLBP Subjects: Male or female aged 18-60 years; females must be postmenopausal or surgically sterilized; chronic pain located below 12th rib and above lower gluteal fold of at least 6 months duration and meeting protocol-specified pain severity criteria; must be currently taking an NSAID, atypical analgesic (e.g. tramadol or tapentadol), or opioid analgesic for CLBP with inadequate analgesia.
Exclusion criteria
Healthy Volunteers: Any clinically significant medical problems.
CLBP Subjects: Any radiation of pain below the lower gluteal fold; any back injury within 3 months prior to study drug; history of back surgery within 1 year prior to study drug; radiographic evidence (x-ray) of osteoarthritis (OA) in any shoulder, hip or knee joint; history of osteonecrosis (avascular necrosis) or rapidly progressive OA in any joint; use of corticosteroids within the past year that meets protocol-specified criteria.
Design
Recruitment
Medical products/devices used
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 | EUCTR2012-002505-21-NL |
| CCMO | NL41463.056.12 |