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.

NCT ID: NCT05178550

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-17
• Study Completion Date: 2022-01-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Heparin

Intervention Type: DRUG

intravenous \[iv\] injection

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

Group Type: EXPERIMENTAL

Heparin

Intervention Type: DRUG

intravenous \[iv\] injection

Interventions

Heparin

intravenous \[iv\] injection

Intervention Type: DRUG

Eligibility 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 (e.g. vegetarians, vegans and subjects who follow special diets).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

2021-005899-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1270-0957

Identifier Type: OTHER

Identifier Source: secondary_id

NN6633-4955

Identifier Type: -

Identifier Source: org_study_id