Research Study to Investigate How a Study Medicine (NNC9204- 1177) Affects Blood Levels of Other Medicines in Healthy People

Completed · Phase 1

Conditions studied: Healthy Volunteers, Overweight, Obesity

In brief

The study looks at how the study medicine (NNC9204-1177) affects other medicines in the body. Participants will get the study medicine and 5 other medicines which have all been approved by the authorities. Participants will get 1 injection of the study medicine each week for 11 weeks. The study medicine is injected under the skin in the stomach area. All injections will be given by study staff. Participants will get 5 medicines as tablets, capsules or syrup to be taken with water at the beginning of the study and after 10 weeks of treatment with the study medicine. The study will last for about 4 months. Participants will have 14 visits to the clinic with the study staff and study doctor. Participants will have blood draws and 2 different kinds of electrocardiograms taken during the study. They will be asked about your mental health. People who use any medication, including herbal products, cannot take part in the study. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period or if they use birth control pills or other hormonal birth control products.

Key facts

Study ID

NCT04059367

Run by

Novo Nordisk A/S

People needed

45

Starts

2019-08-15

Expected to finish

2020-01-02

Last updated by the study team

2020-01-22

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, aged 18-60 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 23.0 and 29.9 kg/m\^2 (both inclusive) at screening.
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

You may not qualify if…

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (intra-uterine device (IUD), vasectomised partner or sexual abstinence)
• Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
• Use of prescription medicinal products or non-prescription drugs, except for IUDs, within 14 days prior to the day of screening.
• Use of any herbal medicine known to interfere with the metabolic CYP pathways, such as Hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days prior to the day of screening.

Where it is running

• Novo Nordisk Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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