A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A

Purpose

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.

Condition

  • Haemophilia A

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Sex
Male
Accepts 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 		Participants will receive oral dose of NNC0442-0344 A.
  • Drug: NNC0442-0344 A
    NNC0442-0344 A will be administered orally.
    Other names:
    • Inno8
Experimental
Cohort 2 		Participants will receive oral dose of NNC0442-0344 A.
  • Drug: NNC0442-0344 A
    NNC0442-0344 A will be administered orally.
    Other names:
    • Inno8
Experimental
Cohort 3 		Participants will receive oral dose of NNC0442-0344 A.
  • Drug: NNC0442-0344 A
    NNC0442-0344 A will be administered orally.
    Other names:
    • Inno8

Recruiting Locations

Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana 46260

University of Iowa_Iowa City
Iowa City, Iowa 52242

Penn State MS Hershey Med Ctr
Hershey, Pennsylvania 17033-2360

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com