Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets
2026年7月23日 更新者:Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Single-center, Open-label, Single-dose, Fixed-dose Regimen, Self-controlled Phase I Clinical Trial to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the pH-dependent Pharmacokinetics of TQ05105 Tablets
Primary objective:
To evaluate the effect of rabeprazole on the primary pharmacokinetics of TQ05105 tablets.
Secondary objective:
To assess the safety and tolerability of single oral administration of TQ05105 tablets alone and in combination with rabeprazole in healthy study participants.
To evaluate the effect of rabeprazole on the secondary PK parameters of TQ05105 and the pharmacokinetics of its active metabolite TQ12550.
調査の概要
研究の種類
介入
入学 (実際)
17
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
-
-
Hunan
-
Changsha、Hunan、中国、410013
- The Third Xiangya Hospital, Central South University
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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:
- Signed informed consent prior to the study, fully understood the study content, procedures and potential adverse reactions; able to complete the study per protocol requirements.
- The participant (including partner) agrees not to plan pregnancy, sperm donation or egg donation from screening until 6 months after the last study drug administration, and is willing to use effective contraception.
- Healthy male and female participants aged 18-45 years (inclusive).
- Male body weight ≥ 50.0 kg; female body weight ≥ 45.0 kg.BMI = weight (kg)/height² (m²), range 18.0-28.0 kg/m² (inclusive).
Exclusion Criteria:
- Participants with clinically significant abnormalities in vital signs, physical examination, ECG or clinical laboratory tests, and deemed unsuitable for participation by the investigator.
- Participants with severe or chronic diseases of the circulatory, digestive, respiratory, urinary, nervous, hematologic, endocrine/metabolic, neoplastic, immune or psychiatric systems within the past 1 year or currently, or any other disease that may interfere with study results.
- Platelet count or absolute neutrophil count below the lower limit of the reference range at screening.
- Any disease increasing bleeding risk, such as hemorrhoids, acute gastritis, gastric or duodenal ulcer.
- Alanine aminotransferase (ALT) > 1.2×ULN, aspartate aminotransferase (AST) > 1.2×ULN, alkaline phosphatase (ALP) > 1.2×ULN, total bilirubin (TBIL) > 1.2×ULN, or any clinically significant abnormality judged by the investigator.
- Any malignancy within the past 5 years.
- Any condition that may affect absorption, distribution, metabolism or excretion of study drug (e.g., inability to swallow), or history of gastrointestinal resection that may affect drug disposition.
- Allergy to rabeprazole, TQ05105 or their excipients; or history of multiple allergies (≥2 substances), including drug allergy, and tendency to develop rash, eczema, urticaria, asthma, etc.
- Use of any strong or moderate inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C19 within 4 weeks prior to screening.
- Use of any prescription drugs, over the counter medications, herbal medicines or dietary supplements (e.g., vitamins, calcium supplements) within 4 weeks prior to screening.
- Use of any acid suppressive therapy within 3 months prior to screening.
- Participation in any clinical trial involving investigational drugs within 3 months prior to screening or within 5 half lives of the study drug (whichever is longer).
- Positive results for HIV antibody, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) or syphilis antibody.
- Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m² at screening.
- Average daily cigarette consumption >5 cigarettes within 3 months prior to screening.
- History of drug abuse within 3 months prior to screening, or positive urine drug screen.
- Regular alcohol consumption within 3 months prior to screening (≥14 units/week; 1 unit = 360 mL beer / 45 mL 40% spirits / 150 mL wine), or positive alcohol breath test.
- Blood donation or blood loss ≥200 mL, or plasma exchange within 4 weeks prior to screening.
- Consumption of alcohol (or positive alcohol breath test), grapefruit juice, coffee, tea, cola, chocolate or related food/beverage within 72 hours before dosing.
- Pregnant or breastfeeding female participants, positive serum pregnancy test, or unprotected sexual intercourse within 2 weeks prior to screening for women of childbearing potential.
- Strenuous exercise (e.g., marathon, weightlifting) within 2 weeks prior to screening.
- Any other condition deemed unsuitable for participation by the investigator.
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:他の
- 割り当て:なし
- 介入モデル:順次割り当て
- 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 |
|---|---|
|
他の:TQ05105 tablets
TQ05105 tablets combined with rabeprazole sodium enteric-coated tablets, 14 days as a treatment cycle.
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TQ05105 tablets are Janus kinase (JAK) inhibitors.
Rabeprazole sodium enteric-coated tablets.
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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 |
|---|---|---|
|
Peak concentration (Cmax)
時間枠:1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
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Maximum plasma drug concentration.
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1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
|
|
Area under the plasma concentration-time curve ( AUC0-t)
時間枠:1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
|
The area enclosed by the blood concentration curve to the timeline.
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1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum concentration (Tmax)
時間枠:1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
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The time required to reach peak concentration after administration.
|
1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
|
|
Plasma clearance (CL/F)
時間枠:1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
|
How much of the plasma is cleared per unit of time.
|
1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
|
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Plasma elimination half-life (t1/2)
時間枠:1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
|
The time it takes for the terminal phase blood concentration to drop by half.
|
1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
|
|
Area under the plasma concentration-time curve ( AUC0-∞)
時間枠:1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
|
The area enclosed by the blood concentration curve to the timeline.
|
1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
|
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Adverse event rate
時間枠:14 days after the first dose
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The occurrence of all adverse events (AEs), and serious adverse events (SAEs).
|
14 days after the first dose
|
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Hematology
時間枠:14 days after the first dose
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Abnormal hematology
|
14 days after the first dose
|
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Serum biochemistry
時間枠:14 days after the first dose
|
Abnormal serum biochemistry
|
14 days after the first dose
|
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Coagulation
時間枠:14 days after the first dose
|
Abnormal coagulation
|
14 days after the first dose
|
|
Urinalysis
時間枠:14 days after the first dose
|
Abnormal urinalysis
|
14 days after the first dose
|
|
Blood pressure
時間枠:14 days after the first dose
|
Abnormal blood pressure
|
14 days after the first dose
|
|
Pulse
時間枠:14 days after the first dose
|
Abnormal pulse
|
14 days after the first dose
|
|
Respiration
時間枠:14 days after the first dose
|
Abnormal respiration
|
14 days after the first dose
|
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Body temperature
時間枠:14 days after the first dose
|
Abnormal body temperature
|
14 days after the first dose
|
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12-lead ECG
時間枠:14 days after the first dose
|
Abnormal 12-lead ECG
|
14 days after the first dose
|
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Physical examination
時間枠:14 days after the first dose
|
Abnormal physical examination
|
14 days after the first dose
|
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Symptoms
時間枠:14 days after the first dose
|
Abnormal symptoms
|
14 days after the first dose
|
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。
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20日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2026年5月20日
QC基準を満たした最初の提出物
2026年5月20日
最初の投稿 (実際)
2026年5月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月27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23日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TQ05105-I-09
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
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