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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
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.
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.
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.
NNC0480-0389 will be administered at a dose of 0.60 mL once weekly by s.c. (under the skin) injections for 14 weeks.
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.
Novo Nordisk Investigational Site
Berlin, Germany
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
Time frame: From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
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
Time frame: From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
Maximum concentration of ethinylestradiol at steady state (Cmax,EE,SS)
Measured in pg/mL
Time frame: Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
Maximum concentration of levonorgestrel at steady state (Cmax,LN,SS)
Measured in pg/mL
Time frame: Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100
Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal (AUC0-60min,para)
Measured in h\*μg/mL
Time frame: From pre-dose to 60 minutes after dosing of paracetamol on day 1 and day 93
Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal (AUC0-300min,para)
Measured in h\*μg/mL
Time frame: From pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93
Maximum observed paracetamol concentration following a standardised meal (Cmax,para)
Measured in μg/mL
Time frame: Within pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93
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