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Investigation of Pharmacokinetics, Safety and Tolerability of Oral NNC0385-0434 in Participants With Various Degrees of Impaired Renal Function and in Participants With Normal Renal Function
Novo Nordisk is developing a new medicine, NNC0385-0434, to help people lower their cholesterol level. The aim of this study is to look at how NNC0385-0434 works in the body and how it is removed from the body in people with impaired kidney function. All participants will receive the same dose (100 mg) of the study medicine NNC0385-0434, which will be given for 10 days in a row. Participants will get the study medicine in a tablet taken orally once-daily. The study medicine needs to be taken in the morning after overnight fasting and 30 minutes before the first meal of the day. The study will last for about 9-14 weeks. Participants will have 15 visits to the study centre, including 2 in-house stays of 3 days and 2 nights and 13 ambulatory visits. Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood draws, urine will be collected and electrocardiograms (ECGs) will be recorded. Participants cannot take part in the study if they have gastrointestinal disorders or unusual meal habits and special dietary requirements. Women can only take part in the study if they cannot get pregnant.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Novo Nordisk Investigational Site
Berlin, Germany
Start Date
November 9, 2021
Primary Completion Date
July 15, 2022
Completion Date
August 24, 2022
Last Updated
December 26, 2023
60
ACTUAL participants
NNC0385-0434 A 100 mg
DRUG
Lead Sponsor
Novo Nordisk A/S
NCT07241390
NCT06926660
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06717698