Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Hepatic Function
This clinical research trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities.
The aim of this clinical research trial is to investigate whether the pharmacokinetics (PK) of petrelintide will be different in people with hepatic impairment (HI) compared to people with normal hepatic function.
調査の概要
詳細な説明
This is a Phase 1, open-label, multicenter, single-dose, parallel-group, non-randomized trial to evaluate the PK, safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe HI, and participants with normal hepatic function. Allocation of participants to the hepatic function groups will be based on Child-Pugh classification.
Each participant will receive a single subcutaneous (SC) dose of petrelintide on Day 1.
Up to 18 participants with normal hepatic function and 18 participants with HI (6 participants each in the following groups: mild, moderate, or severe HI) will participate in this trial.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Clinical Trial Information Desk
- 電話番号：+4588773600
- メール：clinicaltrials@zealandpharma.com
研究場所
-
-
Bratislava Region
-
Bratislava、Bratislava Region、スロバキア、831 01
- 募集
- Summit Clinical Research s.r.o.
-
コンタクト：
- Viera Kupčová, Dr.
- 電話番号：+421905286213
- メール：viera.kupcova@summit-cr.eu
-
-
Malacky
-
Malacky、Malacky、スロバキア、901 01
- 募集
- Summit Clinical Research s.r.o.
-
コンタクト：
- Edita Kadlubiaková, Dr.
- 電話番号：+421905434699
- メール：edita.kadlubiakova@summit-cr.eu
-
-
-
-
Poland
-
Wroclaw、Poland、ポーランド、51-162
- 募集
- Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
-
コンタクト：
- Piotr Napora, Dr.
- 電話番号：+483267900
- メール：napora.piotr@cbk.wroc.pl
-
-
参加基準
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
説明
Inclusion Criteria:
All participants:
- Sex: male and female participants.
Body mass index (BMI): 18.5 to 40.0 kg/m^2, inclusive, at screening.
Additional Inclusion Criteria for Participants with Normal Hepatic Function
- Participants who are considered healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening..
Clinical laboratory test results within normal reference range for the population, or results with acceptable deviations that are judged not to be clinically significant by the Investigator.
Additional Inclusion Criteria for Participants with Hepatic Impairment
- Participants with stable HI for at least 3 months, classified as Child-Pugh Grade A, B, or C as assessed by the Investigator.
- Participants should be otherwise judged to be in acceptable health (type 2 diabetes mellitus [T2DM] is allowed) in the opinion of the Investigator based on a medical evaluation (including a physical examination, medical history, electrocardiogram [ECG], vital signs, concomitant medication and the results of laboratory safety tests) performed during the screening visit.
- Participants with T2DM may be enrolled if they have/are: a. Hemoglobin A1c ≤11% at screening b. On a stable regimen for at least 8 weeks prior to screening, defined as: stable diet and exercise program, and/or, stable dose of metformin, and/or, stable dose of a sodium-glucose cotransporter-2 inhibitor.
Exclusion Criteria:
All participants:
- Known or suspected hypersensitivity to the IMP or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
研究計画
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：非ランダム化
- 介入モデル：並列代入
- 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：Petrelintide: Normal Hepatic Function
Participants with normal hepatic function will receive a single SC dose of petrelintide.
|
Petrelintide will be administered as a single SC injection.
他の名前：
|
|
実験的：Petrelintide: Mild HI
Participants with mild HI will receive a single SC dose of petrelintide.
|
Petrelintide will be administered as a single SC injection.
他の名前：
|
|
実験的：Petrelintide: Moderate HI
Participants with moderate HI will receive a single SC dose of petrelintide.
|
Petrelintide will be administered as a single SC injection.
他の名前：
|
|
実験的：Petrelintide: Severe HI
Participants with severe HI will receive a single SC dose of petrelintide.
|
Petrelintide will be administered as a single SC injection.
他の名前：
|
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 |
時間枠 |
|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Petrelintide
時間枠：Day 1 (pre-dose) to Day 50 (Follow-up)
|
Day 1 (pre-dose) to Day 50 (Follow-up)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
AUC from Time Zero up to Time of Last Measurable Concentration (AUC0-last) of Petrelintide
時間枠：Day 1 (pre-dose) to Day 50 (Follow-up)
|
Day 1 (pre-dose) to Day 50 (Follow-up)
|
|
Maximum Observed Plasma Concentration (Cmax) of Petrelintide
時間枠：Day 1 (pre-dose) to Day 50 (Follow-up)
|
Day 1 (pre-dose) to Day 50 (Follow-up)
|
|
Time to Cmax (tmax)
時間枠：Day 1 (pre-dose) to Day 50 (Follow-up)
|
Day 1 (pre-dose) to Day 50 (Follow-up)
|
|
Apparent Clearance (CL/F) of Petrelintide
時間枠：Day 1 (pre-dose) to Day 50 (Follow-up)
|
Day 1 (pre-dose) to Day 50 (Follow-up)
|
|
Terminal Elimination Half-life (t1/2) of Petrelintide
時間枠：Day 1 (pre-dose) to Day 50 (Follow-up)
|
Day 1 (pre-dose) to Day 50 (Follow-up)
|
|
Apparent Volume of Distribution at Terminal Phase (Vz/F) of Petrelintide
時間枠：Day 1 (pre-dose) to Day 50 (Follow-up)
|
Day 1 (pre-dose) to Day 50 (Follow-up)
|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
時間枠：Day 1 up to Day 50
|
Day 1 up to Day 50
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Clinical Trial Information Desk、Zealand Pharma A/S
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- ZP8396-25077
- Universal Trial number (その他の識別子：U1111-1328-8578)
- 2025-523641-10-00 (Ctis)
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?
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
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。