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

An Open-label, Single-sequence, Crossover Trial Investigating the Influence of NNC9204-1177 on Pharmacokinetics of Index Substrates for Cytochrome P450 Enzymes

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Healthy Volunteers
• Intervention / Treatment: Drug: NNC9204-1177; Drug: Cocktail of 5 already approved drugs

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC9204-1177 and cocktail of approved drugs	Drug: NNC9204-1177; Increasing doses of NNC9204-1177 administered s.c. (subcutaneously, under the skin) in the stomach area once-weekly for 11 weeks; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration-time curve extrapolated to infinity of the caffeine	ng*h/mL	From 0 to 24 hours after a single dose of caffeine without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)
Area under the plasma concentration-time curve extrapolated to infinity of the omeprazole	ng*h/mL	From 0 to 8 hours after a single dose of omeprazole without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)
Area under the plasma concentration-time curve extrapolated to infinity of the midazolam	ng*h/mL	From 0 to 12 hours after a single dose of midazolam without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)
Area under the plasma concentration-time curve extrapolated to infinity of the s-warfarin	ng*h/mL	From 0 to 168 hours after a single dose of warfarin without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)
Area under the plasma concentration-time curve extrapolated to infinity of the dextromethorphan	ng*h/mL	From 0 to 72 hours after a single dose of dextromethorphan without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma caffeine concentration after a single dose	ng/mL	From 0 to 24 hours after a single dose of caffeine without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)
Maximum observed plasma omeprazole concentration after a single dose	ng/mL	From 0 to 8 hours after a single dose of omeprazole without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)
Maximum observed plasma s-warfarin concentration after a single dose	ng/mL	From 0 to 168 hours after a single dose of warfarin without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)
Maximum observed plasma midazolam concentration after a single dose	ng/mL	From 0 to 12 hours after a single dose of midazolam without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)
Maximum observed plasma dextromethorphan concentration after a single dose	ng/mL	From 0 to 72 hours after a single dose of dextromethorphan without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): January 2, 2020
• Study Completion (Actual): January 2, 2020

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: NN9277-4555; U1111-1232-7100 Trial (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No