A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy People
NCT ID: NCT07238816
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
80 participants
INTERVENTIONAL
2025-11-18
2026-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Participants will receive oral dose of NNC0442-0344 A.
NNC0442-0344 A
NNC0442-0344 A will be administered orally.
Group B
Participants will receive oral dose of NNC0442-0344 A.
NNC0442-0344 A
NNC0442-0344 A will be administered orally.
Group C
Participants will receive oral dose of NNC0442-0344 A.
NNC0442-0344 A
NNC0442-0344 A will be administered orally.
Reference dose
Participants will receive oral dose of NNC0442-0344 A.
NNC0442-0344 A
NNC0442-0344 A will be administered orally.
Interventions
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NNC0442-0344 A
NNC0442-0344 A will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
MALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Altasciences Clinical LA, Inc.
Cypress, California, United States
Countries
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Central Contacts
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Other Identifiers
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Universal Trial Number
Identifier Type: OTHER
Identifier Source: secondary_id
NN7442-8255
Identifier Type: -
Identifier Source: org_study_id