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)

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Page 1 of 1 (1 locations)

1

Altasciences Clinical LA, Inc.

Cypress, California, United States, 90630