A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults
2026年7月27日 更新者：AstraZeneca
A Phase I, Randomized, Open-label, 4-period, 4-treatment, Single-dose, Cross-over Study to Assess the Relative Bioavailability of Laroprovstat/Ezetimibe Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults
The purpose of this study is to assess how well laroprovstat and ezetimibe combined in a single tablet to be taken by mouth works and what the body does to the drug (pharmacokinetics) compared with laroprovstat and ezetimibe individual tablets to be taken by mouth (relative bioavailability) as well as to see if there is any effect of eating compared to fasting (food effect) in healthy adults.
調査の概要
状態
積極的、募集していない
条件
詳細な説明
This is a randomized, open-label, 4-period, single-dose, cross-over study.
The study will comprise of a screening period, 4 treatment periods, and 3 washout periods. The following treatments will be given during the study:
- Treatment A: laroprovstat/ezetimibe fixed combination drug product (FCDP) test formulation in fasted state
- Treatment B: laroprovstat tablet plus ezetimibe reference formulations in fasted state
- Treatment C: laroprovstat/ezetimibe FCDP test formulation in fed state
- Treatment D: laroprovstat/ezetimibe FCDP test formulation-slow variant in fasted state
Participants will be randomly assigned to either of the 3 treatment sequences: ABCD, BCAD, or CABD.
研究の種類
介入
入学 (実際)
18
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。
研究場所
-
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Maryland
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Brooklyn、Maryland、アメリカ、21225
- Research Site
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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
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Healthy male and female participants aged 18 to 55 years at the time of signing consent.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Have a Body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
Exclusion Criteria:
- History of any clinically important disease or disorder.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to laroprovstat or ezetimibe.
- Treatment with any lipid lowering therapy or laroprovstat within the 3 months prior to the Screening Visit.
- Treatment with drugs for reduction or inhibition of Proprotein convertase subtilisin/kexin type 9 (PCSK9) within the last 12 months prior to the Screening Visit or inclisiran at any time.
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：Treatment A
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state.
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Laroprovstat/ezetimibe will be administered orally.
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実験的：Treatment B
Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state.
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Laroprovstat will be administered orally.
Ezetimibe will be administered orally.
|
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実験的：Treatment C
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state.
|
Laroprovstat/ezetimibe will be administered orally.
|
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実験的：Treatment D
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state.
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Laroprovstat/ezetimibe slow variant will be administered orally
|
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 concentration-time curve from time 0 to infinity (AUCinf)
時間枠：Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
|
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
|
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
時間枠：Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
|
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
|
Maximum observed drug concentration (Cmax)
時間枠：Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
|
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Plasma Time to reach maximum observed concentration (tmax)
時間枠：Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
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To examine the pharmacokinetic (PK) profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
|
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
|
Terminal elimination half-life (t½λz)
時間枠：Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
|
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
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Apparent total body clearance (CL/F)
時間枠：Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
|
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
|
Apparent volume of distribution based on the terminal phase (Vz/F)
時間枠：Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
|
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
|
AUCinf
時間枠：Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
|
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
|
AUClast
時間枠：Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
|
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
|
Cmax
時間枠：Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
|
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
|
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
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
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6月10日
一次修了 (推定)
2026年9月7日
研究の完了 (推定)
2026年9月7日
試験登録日
最初に提出
2026年5月28日
QC基準を満たした最初の提出物
2026年5月28日
最初の投稿 (実際)
2026年6月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月28日
QC基準を満たした最後の更新が送信されました
2026年7月27日
最終確認日
2026年7月1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
- D7963C00001
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?
はい
IPD プランの説明
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 共有時間枠
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 共有アクセス基準
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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
はい
米国FDA規制機器製品の研究
いいえ
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