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Completed

NCT Number: NCT05178550

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.

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Novo Nordisk Investigational Site

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Heparin

Drug

intravenous [iv] injection

Primary outcomes

  1. Change from baseline in Lipoprotein Lipase (LPL) levels before and after heparin exposure both in fasted and postprandial state

    Time frame: day -1 to day 6

    ng/ml

  2. Change from baseline in LPL activity before and after heparin exposure both in fasted and postprandial state

    Time frame: day -1 to day 6

    µmol/l/min

  3. Change from baseline in Triglycerides (TG) levels before and after heparin exposure both in fasted and postprandial state

    Time frame: day -1 to day 6

    mmol/L

Secondary outcomes

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

    Time frame: day -1 to day 6

    mg/L

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

    Time frame: day -1 to day 6

    mg/dl

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

    Time frame: day -1 to day 6

    mmol/L

  4. Change from baseline in Free fatty acids (FFA) levels before and after heparin exposure both in fasted and postprandial state

    Time frame: day -1 to day 6

    mmol/L

  5. 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

    Time frame: day -1 to day 6

    mmol.L-1

  6. Change from baseline in adverse events (AEs) before and after heparin exposure both in fasted and postprandial state

    Time frame: day -1 to day 6

    Number of events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2022
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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