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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059367
• Other study ID #: NN9277-4555
• Secondary ID: U1111-1232-7100
• Status: Completed
• Phase: Phase 1
• Start date: August 15, 2019
• Est. completion date: January 2, 2020

Study information

• Verified date: January 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Obesity
• Overweight

Intervention

Drug:
• NNC9204-1177
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
5 medicines as tablets, capsules or syrup to be taken with water on Day 1 and Day 78 of the study

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)