ICON - location Groningen
Groningen, 9728 NZ, Netherlands
NCT Number: NCT07029568
The study is testing a new study medicine (called NNC0705-0001), as a potential medicine to treat chronic systemic inflammation, which is known for increasing the risk of developing cardiometabolic diseases. The aim of this study is to see if the study medicine is safe, how it works in our body, and what our body does to the study medicine. The participant will either get NNC0705-0001 or placebo (a "dummy medicine" without the active ingredient). Which treatment the participant gets is decided by chance. The study consists of 3 parts: PART A - single ascending dose (SAD); PART B - multiple ascending doses (MAD) and PART C - food effect (FE) on the pharmacokinetic (PK) properties of NNC0705-0001 and will last about 35 days (PART A) and 41 days (PART B and C).
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NNC0705-0001 will be administered orally.
Placebo matching NNC0705-0001 will be administered orally.
Time frame: From time of dosing (day 1) to end of study (day 7)
Measured in number of events.
Time frame: From time of dosing (day 1) to end of study (day 13)
Measured in number of events.
Time frame: From pre-dose (day 1 or day 8) to day 2 or day 9
Measured in Hour x Micromole (hr×μM).
Time frame: From pre-dose (day 1) to day 5
Measured in hr×μM.
Time frame: From pre-dose (day 1) to day 5
Measured in hr×μM.
Time frame: From pre-dose (day 1) to day 5
Measured in micromole (μM).
Time frame: From pre-dose (day 7) to end of study (day 13)
Measured in hr×μM.
Time frame: From pre-dose (day 7) to end of study (day 13)
Measured in μM.
Time frame: From pre-dose (day 1 or day 8) to day 2 or day 9
Measured in μM.
Time frame: From time of dosing (day 1) to end of study (day 12)
Measured in number of events.
Novo Nordisk A/S
Industry
A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Target Engagement of Single and Multiple Oral Administrations of NNC0705-0001 in Healthy Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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