Back to resultsA Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Semaglutide 1.34 mg/mL
Semaglutide 3.0 mg/mL
NNC0480-0389 10 mg/mL
NNC0480-0389 30 mg/mL
Microgynon®
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal female, aged greater than or equal to 45 years at the time of signing informed consent
- Body mass index between 20.0 and 29.9 kilogram per meter square (kg/m^2) (both inclusive)
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion Criteria:
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- HbA1c greater than or equal to 6.5 % (48 millimoles per mole (mmol/mol)) at screening
- Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic cytochrome P450 enzyme (CYP) pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation
- Use of hormone replacement therapy within 4 weeks before first dose of trial product or intention to initiate treatment with hormone replacement therapy during the study
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One-sequence cross-over arm
Arm Description
Outcomes
Primary Outcome Measures
Area under the ethinylestradiol plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,EE,SS)
Measured in h*pg/mL
Area under the levonorgestrel plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,LN,SS)
Measured in h*pg/mL
Secondary Outcome Measures
Maximum concentration of ethinylestradiol at steady state (Cmax,EE,SS)
Measured in pg/mL
Maximum concentration of levonorgestrel at steady state (Cmax,LN,SS)
Measured in pg/mL
Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal (AUC0-60min,para)
Measured in h*μg/mL
Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal (AUC0-300min,para)
Measured in h*μg/mL
Maximum observed paracetamol concentration following a standardised meal (Cmax,para)
Measured in μg/mL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05153564
Brief Title
A Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause
Official Title
Investigation of the Effect of Subcutaneously Co-administered Semaglutide and NNC0480-0389 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Healthy Postmenopausal Females
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
August 13, 2022 (Actual)
Study Completion Date
September 1, 2022 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Novo Nordisk is developing a combination therapy with the investigational drug NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone. The study will investigate the influence of the combination of semaglutide and NNC0480-0389 on the blood levels of a birth control pill (a combined oral contraceptive consisting of ethinylestradiol and levonorgestrel) and paracetamol. Participants will get semaglutide and NNC0480-0389 as injection under the skin of their belly using a pen-injector. The injections will be given once weekly for 14 weeks. Additionally, participants will at two occasions get paracetamol as soluble tablet in connection with a standardised breakfast meal. Further, participants will get the birth control pill in form of tablets in two periods of 8 days each. Participants will get the combination of semaglutide and NNC0480-0389 as well as paracetamol and the combined contraceptive in any case. The study participation will last up to about 24 weeks. Participants will have 25 visits at the study centre. For 4 of the visits participants will stay at the study centre; the remaining visits will be outpatient. Only healthy postmenopausal women can take part in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One-sequence cross-over arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Semaglutide 1.34 mg/mL
Intervention Description
Semaglutide will be administered at a dose of 0.25, 0.50 or 1.0 mg as indicated on scale drum once weekly by subcutaneous (s.c.) (under the skin) injections in the abdomen for 14 weeks.
Intervention Type
Drug
Intervention Name(s)
Semaglutide 3.0 mg/mL
Intervention Description
Semaglutide will be administered at a dose of 2.0 mg corresponding to the increment of 67 (pen injector units) as indicated on scale drum. once weekly by subcutaneous (s.c.) (under the skin) injections in the abdomen for 14 weeks.
Intervention Type
Drug
Intervention Name(s)
NNC0480-0389 10 mg/mL
Intervention Description
NNC0480-0389 will be administered at a dose of 0.23, 0.45 or 0.90 mL once weekly by s.c. (under the skin) injections for 14 weeks.
Intervention Type
Drug
Intervention Name(s)
NNC0480-0389 30 mg/mL
Intervention Description
NNC0480-0389 will be administered at a dose of 0.60 mL once weekly by s.c. (under the skin) injections for 14 weeks.
Intervention Type
Drug
Intervention Name(s)
Microgynon®
Intervention Description
Microgyn® will be given as once daily oral dosing in two periods, each of 8 days' duration. One tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg.
Primary Outcome Measure Information:
Title
Area under the ethinylestradiol plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,EE,SS)
Description
Measured in h*pg/mL
Time Frame
From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
Title
Area under the levonorgestrel plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,LN,SS)
Description
Measured in h*pg/mL
Time Frame
From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
Secondary Outcome Measure Information:
Title
Maximum concentration of ethinylestradiol at steady state (Cmax,EE,SS)
Description
Measured in pg/mL
Time Frame
Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
Title
Maximum concentration of levonorgestrel at steady state (Cmax,LN,SS)
Description
Measured in pg/mL
Time Frame
Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
Title
Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal (AUC0-60min,para)
Description
Measured in h*μg/mL
Time Frame
From pre-dose to 60 minutes after dosing of paracetamol on day 1 and day 93
Title
Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal (AUC0-300min,para)
Description
Measured in h*μg/mL
Time Frame
From pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93
Title
Maximum observed paracetamol concentration following a standardised meal (Cmax,para)
Description
Measured in μg/mL
Time Frame
Within pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Postmenopausal female, aged greater than or equal to 45 years at the time of signing informed consent
Body mass index between 20.0 and 29.9 kilogram per meter square (kg/m^2) (both inclusive)
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion Criteria:
Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
HbA1c greater than or equal to 6.5 % (48 millimoles per mole (mmol/mol)) at screening
Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic cytochrome P450 enzyme (CYP) pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation
Use of hormone replacement therapy within 4 weeks before first dose of trial product or intention to initiate treatment with hormone replacement therapy during the study
Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency dept. 1452
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
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
A Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause
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