Actively Recruiting

Phase 1
Age: 18Years - 45Years
MALE
Healthy Volunteers
NCT07238816

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

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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

Age: 18Years - 45Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Altasciences Clinical LA, Inc.

Cypress, California, United States, 90630

Actively Recruiting

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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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