Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants
2026年8月8日 更新者：Bayer
A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants
This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form.
About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
100
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Bayer Clinical Trials Contact
- 電話番号：(+)1-888-84 22937
- メール：clinical-trials-contact@bayer.com
研究場所
-
-
Quebec
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Mount Royal、Quebec、カナダ、H3P 3P1
- 募集
- Altasciences
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Female participants aged 18 to 65 years (inclusive) at the time of signing informed consent.
- Participants must be overtly healthy as determined by the investigator based on medical history, physical examination, vital signs, ECG, and clinical laboratory assessments.
- Body weight ≥50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at screening.
- Women of childbearing potential must agree to use a highly effective method of contraception during the study and until 14 days after last administration of study intervention.
- Signed informed consent obtained prior to any study-specific procedures.
Exclusion Criteria:
- Diseases or conditions that may affect absorption, distribution, metabolism, elimination, or effects of the study intervention(s).
- Known or suspected hypersensitivity to the study intervention(s) or their excipients.
- Severe allergies or clinically significant hypersensitivity reactions (e.g. allergic asthma, urticaria, or steroid-requiring allergies).
- Febrile illness within 2 weeks prior to first administration of study intervention.
- History of clinically relevant seizures or endometrial tumors.
- Use of moderate or strong CYP3A4 inhibitors or inducers within 4 weeks prior to first study intervention.
- Participation in another clinical study within 30 days prior to first study intervention or concurrent participation in another trial.
- Clinically relevant abnormal laboratory findings at screening, including elevated liver enzymes or positive virology tests.
- Positive pregnancy test at screening or prior to dosing, or breastfeeding. Positive drug abuse or alcohol test at screening.
- Smoking more than 10 cigarettes per day within 3 months prior to screening.
- Special diets incompatible with study requirements or inability to comply with study procedures.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Sequence 1: Treatment A followed by Treatment B
Participants receive Treatment A followed by Treatment B in a randomized 2 x 2 crossover design with two treatment periods.
|
Elinzanetant treatment A is administered orally once daily.
Elinzanetant treatment B is administered orally once daily.
|
|
実験的：Sequence 2: Treatment B followed by Treatment A
Participants receive Treatment B followed by Treatment A in a randomized 2 x 2 crossover design with two treatment periods.
|
Elinzanetant treatment A is administered orally once daily.
Elinzanetant treatment B is administered orally once daily.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md)
時間枠：On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
elinzanetant administered in the evening 3 hours after a light dinner.
|
On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
|
Maximum Observed Plasma Concentration After Multiple Dosing (Cmax,md)
時間枠：On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
elinzanetant administered in the evening 3 hours after a light dinner.
|
On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
|
Minimum Observed Plasma Concentration During Dosing Interval After Multiple Dosing (Cmin,md)
時間枠：On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
elinzanetant administered in the evening 3 hours after a light dinner.
|
On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number and Severity of Treatment-Emergent Adverse Events (TEAEs)
時間枠：From first dose of study intervention through Day 12 of Period 2 (each treatment period is 12 days)
|
From first dose of study intervention through Day 12 of Period 2 (each treatment period is 12 days)
|
|
|
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Single Dose (AUC(0-24))
時間枠：On Day 2 of each 12-day treatment period
|
elinzanetant administered in the evening under fasted conditions.
|
On Day 2 of each 12-day treatment period
|
|
Maximum Observed Plasma Concentration After Single Dose (Cmax)
時間枠：On Day 2 of each 12-day treatment period
|
elinzanetant administered in the evening under fasted conditions.
|
On Day 2 of each 12-day treatment period
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月22日
一次修了 (推定)
2027年2月22日
研究の完了 (推定)
2027年2月22日
試験登録日
最初に提出
2026年7月15日
QC基準を満たした最初の提出物
2026年8月8日
最初の投稿 (実際)
2026年8月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月13日
QC基準を満たした最後の更新が送信されました
2026年8月8日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 22791
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing".
This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research.
This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research.
Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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