Back to resultsResearch Study to Investigate How a Study Medicine (NNC9204- 1177) Affects Blood Levels of Other Medicines in Healthy People
Primary Purpose
Healthy Volunteers, Overweight, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC9204-1177
Cocktail of 5 already approved drugs
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility Criteria
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.
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NNC9204-1177 and cocktail of approved drugs
Arm Description
Outcomes
Primary Outcome Measures
Area under the plasma concentration-time curve extrapolated to infinity of the caffeine
ng*h/mL
Area under the plasma concentration-time curve extrapolated to infinity of the omeprazole
ng*h/mL
Area under the plasma concentration-time curve extrapolated to infinity of the midazolam
ng*h/mL
Area under the plasma concentration-time curve extrapolated to infinity of the s-warfarin
ng*h/mL
Area under the plasma concentration-time curve extrapolated to infinity of the dextromethorphan
ng*h/mL
Secondary Outcome Measures
Maximum observed plasma caffeine concentration after a single dose
ng/mL
Maximum observed plasma omeprazole concentration after a single dose
ng/mL
Maximum observed plasma s-warfarin concentration after a single dose
ng/mL
Maximum observed plasma midazolam concentration after a single dose
ng/mL
Maximum observed plasma dextromethorphan concentration after a single dose
ng/mL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04059367
Brief Title
Research Study to Investigate How a Study Medicine (NNC9204- 1177) Affects Blood Levels of Other Medicines in Healthy People
Official Title
An Open-label, Single-sequence, Crossover Trial Investigating the Influence of NNC9204-1177 on Pharmacokinetics of Index Substrates for Cytochrome P450 Enzymes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
January 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Single-sequence, cross-over drug interaction trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC9204-1177 and cocktail of approved drugs
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NNC9204-1177
Intervention Description
Increasing doses of NNC9204-1177 administered s.c. (subcutaneously, under the skin) in the stomach area once-weekly for 11 weeks
Intervention Type
Drug
Intervention Name(s)
Cocktail of 5 already approved drugs
Intervention Description
5 medicines as tablets, capsules or syrup to be taken with water on Day 1 and Day 78 of the study
Primary Outcome Measure Information:
Title
Area under the plasma concentration-time curve extrapolated to infinity of the caffeine
Description
ng*h/mL
Time Frame
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)
Title
Area under the plasma concentration-time curve extrapolated to infinity of the omeprazole
Description
ng*h/mL
Time Frame
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)
Title
Area under the plasma concentration-time curve extrapolated to infinity of the midazolam
Description
ng*h/mL
Time Frame
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)
Title
Area under the plasma concentration-time curve extrapolated to infinity of the s-warfarin
Description
ng*h/mL
Time Frame
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)
Title
Area under the plasma concentration-time curve extrapolated to infinity of the dextromethorphan
Description
ng*h/mL
Time Frame
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 Measure Information:
Title
Maximum observed plasma caffeine concentration after a single dose
Description
ng/mL
Time Frame
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)
Title
Maximum observed plasma omeprazole concentration after a single dose
Description
ng/mL
Time Frame
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)
Title
Maximum observed plasma s-warfarin concentration after a single dose
Description
ng/mL
Time Frame
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)
Title
Maximum observed plasma midazolam concentration after a single dose
Description
ng/mL
Time Frame
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)
Title
Maximum observed plasma dextromethorphan concentration after a single dose
Description
ng/mL
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure (1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
Research Study to Investigate How a Study Medicine (NNC9204- 1177) Affects Blood Levels of Other Medicines in Healthy People
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