The purpose of the study is to investigate if NNC0519-0130 affects the blood levels of a birth control pill that contains the two hormones ethinylestradiol and levonorgestrel. The study will also look into if NNC0519-0130 affects how fast stomach is emptied. Participants will get the new study medicine NNC0519-0130 and will also get birth control pills and paracetamol. The study will last for about 35 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
NNC0519-0130 will be administered subcutaneously.
Levonorgestrel + Ethinylestradiol will be administered orally.
Paracetamol will be administered orally.
Parexel International GmbH
Berlin, Germany
Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state
Measured in hours picograms per milliliter (h\*pg/mL).
Time frame: Day 8
Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state
Measured in h\*pg/mL.
Time frame: Day 188
Area under the levonorgestrel plasma concentration time curve during a dosing interval at steady state
Measured in h\*pg/mL.
Time frame: Day 8
Area under the levonorgestrel plasma concentration time curveduring a dosing interval at steady state
Measured in h\*pg/mL.
Time frame: Day 188
Maximum ethinylestradiol plasma concentration at steady state
Measured in picograms per milliliter (pg/mL).
Time frame: Day 8 and Day 188
Maximum levonorgestrel plasma concentration at steady state
Measured in pg/mL.
Time frame: Day 8 and Day 188
Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal
Measured in hours micrograms per milliliter (h\*μg/mL).
Time frame: Day 1 and Day 181
Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal
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Measured in h\*μg/mL.
Time frame: Day 1 and Day 181
Maximum paracetamol plasma concentration following a standardised meal
Measured in micrograms per milliliter (μg/mL).
Time frame: Day 1 and Day 181