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.

NCT05178550 | Completed Early Phase 1

• 3 other identifiers: NN6633-49552021-005899-18U1111-1270-0957
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change from baseline in apolipoprotein CII (APOCII) levels before and after heparin exposure both in fasted and postprandial state

  day -1 to day 6

• Change from baseline in APOCIII levels before and after heparin exposure both in fasted and postprandial state

  day -1 to day 6

• Change from baseline in total cholesterol levels before and after heparin exposure both in fasted and postprandial state

  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

  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

  day -1 to day 6

Study Arms (2)

Group 1 (low dose-high dose)

EXPERIMENTAL

Participants receive 25 IU/kg heparin on days 1 and 2, and 50 IU/kg Heparin on days 4 and 5

Drug: Heparin

Group 2 (high dose-low dose)

EXPERIMENTAL

Participants receive 50 IU/kg heparin on days 1 and 2, and 25 IU/kg Heparin on days 4 and 5

Drug: Heparin

Interventions

Heparin DRUG

intravenous \[iv\] injection

Group 1 (low dose-high dose); Group 2 (high dose-low dose)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subject
• Male or female
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 5, 2022
• Study Start: December 17, 2021
• Primary Completion: January 11, 2022
• Study Completion: January 17, 2022
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)