Status:
COMPLETED
A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers
Hypercholesterolaemia
Eligibility:
MALE
18-70 years
Phase:
PHASE1
Brief Summary
In this study, there are two study medicines: NNC0385-0434 (the new medicine being tested) and placebo (a 'dummy' medicine). Participants will only get one of these medicines - which one is decided by...
Eligibility Criteria
Inclusion
- Healthy volunteers:
- Body mass index between 20.0 kg/m\^2 and 35.0 kg/m\^2 (both inclusive).
- Male subjects.
- Aged 18-55 years (both inclusive) at the time of signing informed consent.
- Patients with hypercholesterolaemia:
- Body mass index between 20.0 kg/m\^2 and 35.0 kg/m\^2 (both inclusive).
- Male subjects.
- Aged 18-70 years (both inclusive) at the time of signing informed consent.
- Stable treatment with high- or moderate-intensity statin defined as total daily dose level of rosuvastatin equal to or above 10 mg, atorvastatin equal to or above 10 mg, simvastatin equal to or above 20 mg, pravastatin equal to or above 40 mg, lovastatin equal to or above 40 mg, fluvastatin equal to or above 80 mg, or pitavastatin equal to or above 1 mg for at least 30 days prior to enrolment and expected to remain on this dose for the remainder of the trial.
Exclusion
- Healthy volunteers:
- Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s) and not using condom with spermicide combined with an effective method of contraception for their female partner(s) in the period from randomisation visit (V2) until 10 weeks following administration of the investigational medical product.
- Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
- Patients with hypercholesterolaemia:
- Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s) and not using condom with spermicide combined with an effective method of contraception for their female partner(s) in the period from randomisation visit (V2) until 10 weeks following administration of the investigational medical product.
- Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
- Current treatment with ezetimibe unless treatment has been with a stable dose for at least 30 days prior to enrolment and expected to remain on this dose for the remainder of the study.
- History (as declared by the subject or reported in the medical records) of heart failure or clinically significant cardiac arrhythmia.
- History (as declared by the subject or reported in the medical records) of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, peripheral vascular or cerebrovascular disease within 12 months prior to enrolment
- Planned surgery or revascularization at time of screening.
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04058834
Start Date
August 20 2019
End Date
April 23 2020
Last Update
December 30 2021
Active Locations (1)
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1
Novo Nordisk Investigational Site
Harrow, United Kingdom, HA1 3UJ