NCT06133270

A First Human Dose Study Investigating Safety and Concentration of Study Medicine in the Blood Following Once Daily Oral Dosing of NNC0560-0004 in Healthy Adults.

A Phase I, Randomised, Double Blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Once-daily Oral Doses of NNC0560-0004 in Healthy Humans, With an Additional Open Label Single Dose Cohort of CYP2D6 Poor Metabolizers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

In this trial, medicine NNC0560-0004 given in capsule form will be compared to placebo in healthy volunteers. Participants will either get NNC0560-0004 or placebo. Which treatment they get is decided by chance. This is a first in human trial, which means that this is the first time that NNC0560-0004 is given to humans. The study will last for about two weeks plus the screening period (approximately 42 days) which in all is about 8 weeks. Women must be of non-childbearing potential thus you cannot take part if you are pregnant, can become pregnant, breast-feeding or plan to get pregnant during the study period.

Conditions

• Healthy Volunteers - Liver Diseases

Interventions

Type	Name	Description
DRUG	NNC0560-0004	NNC0560-0004, Oral administration (taken through the mouth)
DRUG	Placebo (NNC0560-0004)	Placebo matching NNC0560-0004, Oral administration (taken through the mouth)

Timeline

• Start date: 2023-11-13
• Primary completion: 2024-07-04
• Completion: 2024-07-04
• First posted: 2023-11-15
• Last updated: 2025-08-20

Locations

1 site across 1 country: United Kingdom