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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
Altasciences Clinical LA, Inc.
RECRUITING
Cypress
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-11-18
Estimated Completion Date: 2026-04-29
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov

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