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.

Novo Nordisk

Status and phase: Completed; Early Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Heparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05178550

2021-005899-18 (EudraCT Number)

NN6633-4955

U1111-1270-0957 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Group 1 (low dose-high dose)

Experimental group

Description:

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

Treatment:

Drug: Heparin

Group 2 (high dose-low dose)

Experimental group

Description:

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

Treatment:

Drug: Heparin