Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People With Haemophilia A
Novo Nordisk A/S
Summary
This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A. The study medicine is a new medicine that cannot yet be prescribed by doctors. The study will last for about 11 weeks.
Eligibility
- Age range
- 18–64 years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: * Male * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body weight greater than or equal to (≥) 45 kilograms (kgs). * Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records. Exclusion Criteria: * Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening. * Body mass index ≥30.0 kilogram per square meter (kg/m\^2). * Increased risk of t…
Interventions
- DrugNNC0442-0344 A
NNC0442-0344 A will be administered orally.
Locations (33)
- UC Denver Hemoph & Thrombo CtrAurora, Colorado
- Indiana Hemophilia-Thromb CtrIndianapolis, Indiana
- University of Iowa_Iowa CityIowa City, Iowa
- Penn State MS Hershey Med CtrHershey, Pennsylvania
- St Christopher Hosp for ChildPhiladelphia, Pennsylvania
- Universitätsklinik für Innere Medizin VInnsbruck