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

Part of paid clinical trials in Cypress, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT07238816
Phase
PHASE1
Status
Recruiting
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Conditions

  • Haemophilia A

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • NNC0442-0344 A — DRUG
    NNC0442-0344 A will be administered orally.

Study Details

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.

Key Dates

Start date
Nov 18, 2025
Status verified
Dec 2025
Primary completion
Apr 29, 2026
Completion
Apr 29, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Participants will receive oral dose of NNC0442-0344 A.
  • Experimental: Group B
    Participants will receive oral dose of NNC0442-0344 A.
  • Experimental: Group C
    Participants will receive oral dose of NNC0442-0344 A.
  • Active Comparator: Reference dose
    Participants will receive oral dose of NNC0442-0344 A.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Altasciences Clinical LA, Inc.CypressCalifornia90630-

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Altasciences Clinical LA, Inc.· Cypress, CA

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