Actively Recruiting
A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy People
Led by Novo Nordisk A/S · Updated on 2025-12-31
80
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy People
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male
- Age 18-45 years at the time of signing informed consent
- Body mass index between 18.5 and 29.9 kg/m² at screening
- Body weight between 60.0 and 100.0 kg at screening
- Considered generally healthy based on medical history, physical exam, vital signs, ECG, and lab tests at screening as judged by the investigator
You will not qualify if you...
- Factor VIII activity ≥ 150% at screening
- Increased risk of thrombosis, including personal or first-degree family history of unprovoked deep vein thrombosis
- Any clinical signs or diagnosis of venous or arterial thromboembolic disease
- Presence of thrombophilia markers outside normal lab range at screening, including lupus anticoagulant, anti-cardiolipin antibodies, and anti-β2 glycoprotein I antibodies
- Heterozygosity or homozygosity for factor V Leiden or prothrombin mutations, or compound heterozygosity for both
- Protein C, protein S, or antithrombin below normal lab range
- Any known coagulation disorders
- Clinically significant gastrointestinal disorders affecting drug or nutrient absorption as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Altasciences Clinical LA, Inc.
Cypress, California, United States, 90630
Actively Recruiting
Research Team
N
Novo Nordisk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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