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.

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Heparin

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (low dose-high dose); Participants receive 25 IU/kg heparin on days 1 and 2, and 50 IU/kg Heparin on days 4 and 5	Drug: Heparin; intravenous [iv] injection
Experimental: Group 2 (high dose-low dose); Participants receive 50 IU/kg heparin on days 1 and 2, and 25 IU/kg Heparin on days 4 and 5	Drug: Heparin; intravenous [iv] injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change from baseline in APOCIII levels before and after heparin exposure both in fasted and postprandial state	mg/dl	day -1 to day 6
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
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
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
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Actual): January 11, 2022
• Study Completion (Actual): January 17, 2022

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: NN6633-4955; 2021-005899-18 (EudraCT Number); U1111-1270-0957 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No