How eating affects Inno8 absorption in healthy adult men

A Single-centre, Open-label, Randomised, Single-dose Study to Evaluate the Effect of Pre- and Post-dose Meal Timings on the Pharmacokinetic Properties of Inno8 in Healthy Participants

This study tests whether eating or drinking before or after taking Inno8 changes how well the medicine is absorbed in healthy adult men.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Male
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Cypress, California)
• Trial ID: NCT07238816 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional trial gives a single investigational dose of NNC0442-0344 A (Inno8) to healthy adult men to measure how food intake affects absorption. Participants are assigned to one of four arms with different overnight fasting and post-dose fasting/meal timing, and the dose is taken after the assigned fast. Blood samples will be collected over time to measure drug levels and safety will be monitored with standard labs and exams. The overall participation period is up to 9.5 weeks including screening and follow-up.

Who should consider this trial

Good fit: Ideal candidates are generally healthy men aged 18–45 years with BMI 18.5–29.9 kg/m2 and weight 60–100 kg who meet screening health and coagulation criteria.

Not a fit: People with a history or increased risk of thrombosis, abnormal thrombophilia markers, women, or those outside the specified age/weight/BMI ranges (and patients needing immediate haemophilia therapy) are unlikely to receive direct benefit from participation.

Why it matters

Potential benefit: If successful, the results could guide meal-related dosing instructions for Inno8 and help optimize how the drug is given to people with haemophilia A.

How similar studies have performed: Food-effect pharmacokinetic studies for similar therapies are common and have reliably informed dosing, so this approach is standard rather than novel.

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.

Where this trial is running

Cypress, California

• Altasciences Clinical LA, Inc. — Cypress, California, United States (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Haemophilia A