Status:
RECRUITING
A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy People
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Haemophilia A
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test a new medicine called Inno8. The study will test how eating and drinking before and after taking Inno8 affects how well it is absorbed in the stomach. The study co...
Eligibility Criteria
Inclusion Criteria:
- Male.
- Age 18-45 years (both inclusive) at the time of signing informed consent.
- Body mass index between 18.5 and 29.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
- Body weight between 60.0 and 100.0 kilogram (kg) (both inclusive) at screening.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria:
- Factor VIII activity greater than or equal to (≥) 150 percentage (%) at screening.
- Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis.
- Any clinical signs or established diagnosis of venous or arterial thromboembolic disease.
- Any of the thrombophilia markers listed below:
- Lupus anticoagulant, anti-cardiolipin antibody Immunoglobulin G (IgG) and Immunoglobulin M (IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening.
- Heterozygosity or homozygosity for the factor V Leiden mutation (G1691A) OR heterozygosity or homozygosity for the prothrombin mutation (G20210A) OR compound heterozygosity for the factor V Leiden (G1691A) and prothrombin mutation (G20210A).
- Protein C, protein S or antithrombin below the lower normal laboratory range.
- Any known coagulation disorders.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Key Trial Info
Start Date :
November 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 29 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07238816
Start Date
November 18 2025
End Date
April 29 2026
Last Update
December 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Altasciences Clinical LA, Inc.
Cypress, California, United States, 90630