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OpenTrials
Completed

NCT Number: NCT07238816

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical LA, Inc.

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

NNC0442-0344 A

Drug

NNC0442-0344 A will be administered orally.

Other names: Inno8

Primary outcomes

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

    Time frame: From baseline (Day 1) to day 17

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

Secondary outcomes

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

    Time frame: From baseline (Day 1) to day 17

    Measured as nanograms per millilitre (ng/mL).

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

    Time frame: From baseline (Day 1) to day 17

    Measured as hours.

  3. Number of treatment emergent adverse events

    Time frame: From time of dosing (Day 1) to day 36

    Measured as count of events.

  4. Change in D-dimer

    Time frame: From baseline (Day 1) to day 36

    Measured as absolute (ng/mL) and percentage (%).

  5. Change in prothrombin fragment 1 and 2

    Time frame: From baseline (Day 1) to day 36

    Measured as absolute [(picomoles per litre) pmol/L] and %.

  6. Change in fibrinogen

    Time frame: From baseline (Day 1) to day 36

    Measured as absolute [(milligrams per decilitre) mg/dL] and %.

  7. Change in platelets

    Time frame: From baseline (Day 1) to day 36

    Measured as absolute [(ten to the ninth power per litre) 10^9/L] and %.

  8. Change in FIX antigen

    Time frame: From baseline (Day 1) to day 36

    Measured as %.

  9. Change in FX antigen

    Time frame: From baseline (Day 1) to day 36

    Measured as %.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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