Clinical trial NCT05153564: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-12-10
Enrollment: 27
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Area under the ethinylestradiol plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,EE,SS)
timeFrame: From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
measure: Area under the levonorgestrel plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,LN,SS)
timeFrame: From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
Secondary outcomes:
measure: Maximum concentration of ethinylestradiol at steady state (Cmax,EE,SS)
timeFrame: Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
measure: Maximum concentration of levonorgestrel at steady state (Cmax,LN,SS)
timeFrame: Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
measure: Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal (AUC0-60min,para)
timeFrame: From pre-dose to 60 minutes after dosing of paracetamol on day 1 and day 93
measure: Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal (AUC0-300min,para)
timeFrame: From pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93
measure: Maximum observed paracetamol concentration following a standardised meal (Cmax,para)
timeFrame: Within pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 1452
role: STUDY_DIRECTOR
References: