Haemophilia A
Conditions
Brief 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.
Interventions
DRUGNNC0442-0344 A
NNC0442-0344 A will be administered orally.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
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 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 known coagulation disorders other than haemophilia A. * Ongoing or planned immune tolerance induction therapy. * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events | From time of dosing (Day 1) to end of follow-up (Day 46) | Measured as count of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in D-dimer | From time of dosing (Day 1) to end of follow-up (Day 46) | Measured as absolute and percentage (%). |
| Change in prothrombin fragment 1 and 2 | From time of dosing (Day 1) to end of follow-up (Day 46) | Measured as absolute and %. |
| Change in fibrinogen | From time of dosing (Day 1) to end of follow-up (Day 46) | Measured as absolute and %. |
| Change in platelets | From time of dosing (Day 1) to end of follow-up (Day 46) | Measured as absolute and %. |
| Occurrence of anti-Inno8 antibodies | From time of dosing (Day 1) to end of follow-up (Day 46) | Measured as count. |
| Cmax: the maximum concentration of Inno8 after multiple doses | From Day 10 to Day 11 | Measured as nanograms per millilitre (ng/mL). |
| Tmax: the time to Cmax after last multiple dose | From day 10 to Day 11 | Measured as hours. |
| Tmax: the time to Cmax after first dose | From Day 1 to Day 2 | Measured as hours. |
| AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses | From Day 10 to Day 11 | Measured as nanograms\*day per millilitre (ng\*day/mL). |
| Maximum thrombin generation (peak height) | From Day 10 to Day 11 | Measured as nanomolar (nM). |
Countries
Austria, Belgium, France, Germany, Italy, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed