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

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 - Investigation of biomarkers after heparin use

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50416

Enrollment

Registered

2021-11-16

Start date

2021-12-17

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovascular disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To assess lipoprotein lipase (LPL) activity, LPL levels, and triglyceride (TG) levels after heparin exposure in both fasted and postprandial state.	—

Secondary

Measure	Time frame
To assess levels of apolipoprotein CII (APOCII), apolipoprotein CIII (APOCIII), total cholesterol, and free fatty acids (FFAs), and to assess the lipoprotein.	—

Countries

Netherlands

Outcome results