CompletedPhase 1

Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body

Germany16 participantsStarted 2021-04-09

Plain-language summary

Researchers are looking for a new way to treat women who have symptoms by hormonal changes, like those that happen in women during menopause. These symptoms can include hot flashes, night sweats, and changes in blood pressure. These symptoms are caused by hormonal changes occurring during menopausal transition when women may have also changes in their monthly cycles. The menopausal transition most often begins between ages 45 and 55 and leads to menopause, a point in time 12 months after a woman's last period. The study drug, elinzanetant, was designed to treat symptoms caused by hormonal changes. Before a new treatment can be approved for people to take, researchers perform clinical trials to better understand how this treatment works and to investigate safety. The purpose of this study is to assess the blood levels of elinzanetant when given as 2 capsules of dose A (what is intended for further research and future commercialization) and also to compare the blood levels when given as 3 capsules of dose B (what was used for research up to now). Furthermore, researchers want to find out if taking of elinzanetant on two time points leads to differences in blood levels of elinzanetant. This trial will be performed in healthy women aged 40 to 65 years.

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant must be 40 to 65 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure, pulse rate, 12-lead electrocardiogram, body temperature, and laboratory tests. * Non-smoker, at least from 3 months before the screening visit onwards * Body weight of at least 50 kg and BMI within the range 18.0 and 30.0 kg/m\*2 (inclusive) at screening. * Female * Women of childbearing potential will have to use highly effective non-hormonal contraception when having sexual intercourse with a male partner from signing the informed consent form until 5 days after last dose of the study drug. Acceptable methods of contraception for this study are listed in protocol. * Women of non-childbearing potential are not required to use contraception. Non-childbearing potential is defined as * Postmenopausal state confirmed by follicle stimulating hormone (FSH) level \>40 U/L, or above reference range from the local laboratory, or * Surgically sterilized by bilateral tubal ligation, or bilateral oophorectomy with or without hysterectomy documented by medical report verification Exclusion Criteria: * Pregnant or breastfeeding women. * Any clinically relevant abnormal findings in medical history and physical examination which in the opinion of the investigators, may put the participant at risk because of her partici…

What they're measuring

AUC of elinzanetant

Timeframe: Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)

Cmax of elinzanetant

Timeframe: Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)

Trial details

NCT IDNCT04845841

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-01