A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy People

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Haemophilia A

Treatments: Drug: NNC0442-0344 A

Study type: Interventional

Funder types: Industry

Identifiers

NCT07238816

NN7442-8255

Universal Trial Number (Registry Identifier)

Details and patient eligibility

About

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 consists of four arms. Participants will take the study medicine after an overnight fast. How long participants will need to fast depends on which group participants are in. After taking the study medicine, participants will need to fast again. The study will last for up to 9.5 weeks.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Group A

Experimental group

Description:

Participants will receive oral dose of NNC0442-0344 A.

Treatment:

Drug: NNC0442-0344 A

Group B

Experimental group

Description:

Participants will receive oral dose of NNC0442-0344 A.

Treatment:

Drug: NNC0442-0344 A

Group C

Experimental group

Description:

Participants will receive oral dose of NNC0442-0344 A.

Treatment:

Drug: NNC0442-0344 A

Reference dose

Active Comparator group

Description:

Participants will receive oral dose of NNC0442-0344 A.

Treatment:

Drug: NNC0442-0344 A