A Study in Healthy Participants Investigating Biomarkers After Exposure to Heparin When Heparin is Administered in the Fasted State or After a High-fat Meal. Heparin, a Registered Drug, is an Anticoagulant (Blood Thinner) That Prevents the Formation of Blood Clots.

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05178550
• Other study ID #: NN6633-4955
• Secondary ID: 2021-005899-18U1
• Status: Completed
• Phase: Early Phase 1
• Start date: December 17, 2021
• Est. completion date: January 17, 2022

Study information

• Verified date: May 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study biomarkers in the blood after exposure to heparin in the fasted state or after a high-fat meal will be investigated. Heparin will be administered as an intravenous (iv) injection (injection directly in a blood vessel). In this study, the effects of administration of heparin will be compared with the effects of administration of normal saline which will also be administered as an iv injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 17, 2022
• Est. primary completion date: January 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy subject

• Male or female

• 18 to 65 years, inclusive, at the time of signing informed consent

• Body mass index:18.0 kg/m ^2 to 29.9 kg/m^2, inclusive, at the time of signing informed consent

• Body weight greater than or equal to 50 kg at the time of signing informed consent

Exclusion criteria:

• Using tobacco products within 60 days prior to the first drug administration.

• Any kind of coagulation disorder or any first degree family members with major bleeding tendency.

• History of anemia, thrombocytopenia, HIT, other blood disorders, or any clinically relevant bleeding (epistaxis).

• Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 100 days prior to the first dose of heparin.

• Participation in any clinical study of an approved or non-approved investigational medicinal product within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening. If the half-life of the investigational medicinal product is unknown, subjects participating in a clinical trial in the 6 months prior to (the first) treatment administration will be excluded.

• Any kind of coagulation disorder or any first degree family members with major bleeding tendency.

• Unwillingness to consume the entire high-fat standardized meal (e.g. vegetarians, vegans and subjects who follow special diets).

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Heparin
intravenous [iv] injection

Locations

Country	Name	City	State
Netherlands	Novo Nordisk Investigational Site	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Lipoprotein Lipase (LPL) levels before and after heparin exposure both in fasted and postprandial state	ng/ml	day -1 to day 6
Primary	Change from baseline in LPL activity before and after heparin exposure both in fasted and postprandial state	µmol/l/min	day -1 to day 6
Primary	Change from baseline in Triglycerides (TG) levels before and after heparin exposure both in fasted and postprandial state	mmol/L	day -1 to day 6
Secondary	Change from baseline in apolipoprotein CII (APOCII) levels before and after heparin exposure both in fasted and postprandial state	mg/L	day -1 to day 6
Secondary	Change from baseline in APOCIII levels before and after heparin exposure both in fasted and postprandial state	mg/dl	day -1 to day 6
Secondary	Change from baseline in total cholesterol levels before and after heparin exposure both in fasted and postprandial state	mmol/L	day -1 to day 6
Secondary	Change from baseline in Free fatty acids (FFA) levels before and after heparin exposure both in fasted and postprandial state	mmol/L	day -1 to day 6
Secondary	Change from baseline in Lipoprotein profiling (very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL) before and after heparin exposure both in fasted and postprandial state	mmol.L-1	day -1 to day 6
Secondary	Change from baseline in adverse events (AEs) before and after heparin exposure both in fasted and postprandial state	Number of events	day -1 to day 6