NCT07238816CompletedPhase 1
A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy People
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
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 16 Nov 2025
- Start date
- 18 Nov 2025
- Primary completion date
- 8 May 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Haemophilia
- NCT number
- NCT07238816
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 80
- From 18 Nov 2025 to the primary completion date, 8 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Lab values
- 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.
- Protein C, protein S or antithrombin below the lower normal laboratory range.
Other
- Factor VIII activity greater than or equal to (≥) 150 percentage (%) at screening.
- Any of the thrombophilia markers listed below:
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Altasciences Clinical LA, Inc. Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.