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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-15

Study Completion Date

2020-01-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers Overweight Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Single-sequence, cross-over drug interaction trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NNC9204-1177 and cocktail of approved drugs

Group Type EXPERIMENTAL

NNC9204-1177

Intervention Type DRUG

Increasing doses of NNC9204-1177 administered s.c. (subcutaneously, under the skin) in the stomach area once-weekly for 11 weeks

Cocktail of 5 already approved drugs

Intervention Type DRUG

5 medicines as tablets, capsules or syrup to be taken with water on Day 1 and Day 78 of the study

Interventions

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NNC9204-1177

Increasing doses of NNC9204-1177 administered s.c. (subcutaneously, under the skin) in the stomach area once-weekly for 11 weeks

Intervention Type DRUG

Cocktail of 5 already approved drugs

5 medicines as tablets, capsules or syrup to be taken with water on Day 1 and Day 78 of the study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes