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

• Status: Recruiting
• Trial end date: 2022-01-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Heparin

Criteria

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 (eg. vegetarians, vegans and subjects who follow special diets).