Fukuoka Mirai Hospital
Fukuoka, Fukuoka, 813-0017, Japan
NCT Number: NCT07656792
Single dose (SD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of single dose.
Multiple doses (MD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of multiple doses.
Oral contraceptives (OC) part: The main objective of this trial is to investigate the effect of multiple oral doses of BI 3031185 on pharmacokinetics of drospirenone (DRSP) and ethinylestradiol (EE) (YAZ®) in Japanese healthy female trial participants.
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Notify Me18 year–64 year
All sexes
Interventional
Phase 1
Fukuoka, Fukuoka, 813-0017, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BI 3031185
Placebo matching BI 3031185
Midazolam
Other names: Midafresa®
YAZ®
Time frame: Up to 29 days
SD = Single dose
Time frame: Up to 47 days
MD = Multiple doses
Time frame: Up to 29 days
OC = Oral contraceptives
Time frame: Up to 29 days
Time frame: Up to 11 days
Time frame: Up to 11 days
Time frame: Up to 39 days
Time frame: Up to 39 days
Time frame: Up to 29 days
Boehringer Ingelheim
Industry
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of BI 3031185 in Japanese Healthy Male Trial Participants (Single-blind, Randomised, Placebo-controlled, Parallel Group Design) and Effect of Multiple Doses of BI 3031185 on Pharmacokinetics of a Single Dose of a Combination of Drospirenone and Ethinylestradiol (Oral Contraceptive) in Japanese Healthy Female Trial Participants (Non-randomised, Open-label, Fixed Sequence Design)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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