A Phase 1 interventional study of NNC0385-0434 in Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk, Elevated Cholesterol and Healthy Volunteers, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
In this study participants will receive NNC0385-0434. NNC0385-0434 is being developed for the treatment of hypercholesterolemia, a fat metabolism disorder characterized by high levels of cholesterol in the blood. The dose to be tested in this study is 40 mg NNC0385-0434.
NNC0385-0434 is a new potential medicine that is currently being tested for intake as a tablet. It is not yet approved and cannot be prescribed yet. Besides 40 mg of NNC0385-0434, each tablet also contains 500 mg of the absorption enhancing agent SNAC, which helps to move NNC0385-0434 from the stomach into the blood.
The aim of this study is to investigate the effect of food intake on the amount of NNC0385-0434 in the blood after multiple tablet intake. For this purpose, NNC0385-0434 is given either after a high-fat breakfast or on an empty stomach. After dosing, participants must either fast for another 4 hours or receive a meal 30 minutes after dosing, depending on the group participants are assigned to. After taking the NNC0385-0434 tablets, the amount of NNC0385-0434 (and of SNAC) in the blood will be measured. The effect of food intake on the uptake of NNC0385-0434 into the body will be investigated so that correct and safe intake recommendations and medicine labels can be given.
The study can last for up to approximately 14 weeks for each participant, with a total of 7 clinic visits. This includes a screening period (up to 4 weeks) and one in-house treatment period (together a total of 13 consecutive days). It also includes a follow-up period with 5 ambulatory visits at the clinic (for approximately 7 weeks [total of 50 days] after the last dosing). participants will have blood tests at every clinic visit. Participants must be healthy and have a body mass index (BMI) between 20.0 and 34.9 kg/m2 (both inclusive). Only men can participate in this clinical study.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 73 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Fed dosing conditions
Drug: NNC0385-0434
Fasting dosing conditions
Drug: NNC0385-0434
Reference dosing conditions
Drug: NNC0385-0434
All participants will be dosed with 40 mg oral NNC0385-0434 once-daily for 10 consecutive days
AUC0-24h,0434,Day10: the area under the NNC0385-0434 plasma concentration-time curve from 0 to 24 h after last dose of oral NNC0385-0434
h\*nmol/L
Time frame: From last dose (Day 10) to 24 hours post treatment (Day 11)
Cmax,0434,Day10: the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434
nmol/L
Time frame: From last dose (Day 10) to post treatment follow-up (Day 65)
tmax,0434,Day10: the time to maximum observed plasma concentration of NNC0385-0434 after last dose of NNC0385-0434
hours
Time frame: From last dose (Day 10) to post treatment follow-up (Day 65)
t1/2,0434,Day10: the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434
hours
Time frame: From last dose (Day 10) to post treatment follow-up (Day 65)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S