NCT05333107

A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II

A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of NNC0385-0434 to Healthy Male Participants - Oral Formulation II

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.

Conditions

• Healthy Volunteers; High Cholesterol

Interventions

Type	Name	Description
DRUG	NNC0385-0434 G	Participants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
DRUG	NNC0385-0434 F	Participants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
DRUG	NNC0385-0434 B	Participants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).

Timeline

• Start date: 2022-04-12
• Primary completion: 2022-07-22
• Completion: 2022-09-23
• First posted: 2022-04-18
• Last updated: 2024-07-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study