An open-label, randomized, single center, crossover study in healthy participants to assess lipoprotein lipase activity and levels, and triglyceride levels after heparin exposure, in both fasted and postprandial state
- Conditions
- cardiovascular disease10047066
- Registration Number
- NL-OMON50416
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1. Informed consent obtained before any study-related activities. Study-related
activities are any procedures that are carried out as part of the study,
including activities to determine suitability for the study.
2. Healthy male or female, aged 18 years to 65 years (both inclusive) at the
time of signing informed consent.
3. Body mass index 18.0 kg/m2 to 29.9 kg/m2 (both inclusive) at the time of
signing informed consent.
4. Body weight >=50 kg at the time of signing informed consent.
5. Considered to be generally healthy as judged by the Investigator, as defined
by the absence of any clinically significant, active, or chronic disease
evidenced by a detailed medical and surgical history and a complete physical
examination including vital signs, 12 lead ECGs, hematology, clinical
chemistry, coagulation, urinalysis, and serology.
1. Previous participation in the current study.
2. Employee of PRA or the Sponsor.
3. History of relevant drug and/or food allergies.
4. Known or suspected allergy to study drug-related products, including heparin
or pork products.
5. Using tobacco products within 60 days prior to the first drug
administration.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess lipoprotein lipase (LPL) activity, LPL levels, and triglyceride (TG)<br /><br>levels after heparin exposure in both fasted and postprandial state.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess levels of apolipoprotein CII (APOCII), apolipoprotein CIII (APOCIII),<br /><br>total cholesterol, and free fatty acids (FFAs), and to assess the lipoprotein.</p><br>