Ended Human Pharmacology (Phase I)- Other Vasomotor symptoms as a sex hormone-dependent disorder in women and men

A study to learn about how much elinzanetant gets absorbed in the blood and how safe it is in healthy participants when taken as different types of formulations

EU CTIS ID: 2023-503968-16-00

What this study is testing

To investigate the relative bioavailability of two soft gel capsule formulations versus the currently used Phase 3 formulation when administered as single oral dose under fasting conditions

  • Human Pharmacology (Phase I)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Participant must be 18 to 55 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, body temperature, 12-lead ECG, and laboratory tests.

You likely can't join if

  • Pregnant or breastfeeding women.
  • Medical disorder, condition, or history of such that would impair the participant’s ability to take part in or complete this study in the opinion of the investigator. This includes family history indicating hereditary predisposition of relevant diseases and history of non- persisting diseases with possible impact on study participation.
  • Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention(s) will not be normal.
  • Regular use of prescription drugs, over-the-counter drugs, supplements (e.g., carnitine products, anabolics, high dose vitamins) or herbal products.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.