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

NCT07238816 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: NN7442-8255Universal Trial Number
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a new medicine called Inno8. The study will test how eating and drinking before and after taking Inno8 affects how well it is absorbed in the stomach. The study consists of four arms. Participants will take the study medicine after an overnight fast. How long participants will need to fast depends on which group participants are in. After taking the study medicine, participants will need to fast again. The study will last for up to 9.5 weeks.

Conditions

Haemophilia A

Outcome Measures

Primary Outcomes (1)

• AUC0-∞: the area under the plasma Inno8 concentration-time curve from time 0 to infinity after a single oral dose

  Measured as nanograms\*day per millilitre (ng\*day/mL).

  From baseline (Day 1) to day 17

Secondary Outcomes (9)

• Cmax: Maximum observed plasma Inno8 concentration after a single oral dose

  From baseline (Day 1) to day 17

• Tmax: The time to maximum observed plasma Inno8 concentration after a single oral dose

  From baseline (Day 1) to day 17

• Number of treatment emergent adverse events

  From time of dosing (Day 1) to day 36

• Change in D-dimer

  From baseline (Day 1) to day 36

• Change in prothrombin fragment 1 and 2

  From baseline (Day 1) to day 36

Study Arms (4)

Group A

EXPERIMENTAL

Participants will receive oral dose of NNC0442-0344 A.

Drug: NNC0442-0344 A

Group B

EXPERIMENTAL

Participants will receive oral dose of NNC0442-0344 A.

Drug: NNC0442-0344 A

Group C

EXPERIMENTAL

Participants will receive oral dose of NNC0442-0344 A.

Drug: NNC0442-0344 A

Reference dose

ACTIVE COMPARATOR

Participants will receive oral dose of NNC0442-0344 A.

Drug: NNC0442-0344 A

Interventions

NNC0442-0344 A DRUG

NNC0442-0344 A will be administered orally.

Also known as: Inno8

Group A; Group B; Group C; Reference dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Altasciences Clinical LA, Inc.

Cypress, California, 90630, United States

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 18, 2025
• Primary Completion: April 29, 2026
• Study Completion: April 29, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)