What is Inno8 studying for haemophilia A?

Inno8 is being studied to see how eating and drinking before and after taking the medicine affects its absorption in healthy people. This research helps understand how meal timing may influence the medicine's behavior in the body. The study is sponsored by Novo Nordisk A/S and focuses on healthy male participants aged 18 to 45.

Who may be eligible for this haemophilia A clinical trial?

Men aged 18 to 45 years who are generally healthy and meet specific weight and body mass index requirements may be eligible. Participants should not have a history of blood clotting disorders or risk factors for thrombosis. Please review eligibility criteria for more details.

Is there any cost to participate in this haemophilia A clinical trial?

Study-related care, including the study medicine and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 1

Age: 18Years - 45Years

MALE

Healthy Volunteers

ID07238816

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

Led by Novo Nordisk A/S · Updated on 2025-12-31

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new medicine called Inno8 to understand how eating and drinking before and after taking the medicine affects its absorption in the stomach. The study focuses on healthy male participants aged 18 to 45 years and aims to learn how meal timing influences the way Inno8 behaves in the body. This is a Phase 1, randomized, open-label study sponsored by Novo Nordisk AS. Participants will take a single oral dose of Inno8 after fasting overnight, with fasting duration varying depending on the group they are assigned to. The study includes four groups, with each receiving the same oral dose of the medicine but under different meal timing conditions. After taking the dose, participants will fast again as specified by their group. The entire study lasts up to 9.5 weeks. During the study, participants will undergo assessments including blood tests to measure Inno8 concentration over time and monitor safety markers such as clotting factors and adverse events. Researchers will measure how much medicine is absorbed and the timing of peak levels in the blood. Safety evaluations, including laboratory tests and vital signs, will be conducted from the first dose up to 36 days. Participants health will be closely monitored throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years

MALE

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

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/m2) (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 medical history, physical exam, vital signs, electrocardiogram and lab tests as judged by investigator

You will not qualify if you...

Factor VIII activity greater than or equal to 150% at screening
Increased risk of thrombosis, such as personal or first-degree relatives history of unprovoked deep vein thrombosis
Any clinical signs or diagnosis of venous or arterial thromboembolic disease
Presence of thrombophilia markers outside normal lab range at screening
Genetic mutations related to clotting disorders
Protein C, protein S or antithrombin below normal lab range
Any known coagulation disorders
Clinically significant gastrointestinal disorders affecting drug absorption as judged by investigator

Research Team

Novo Nordisk

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