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Drug-Drug Interactions of JMKX003142 in Healthy Participants

2026年4月27日 更新者:Jemincare

A Single-center, Non-randomized, Open-label, Self-controlled, Phase I Clinical Study to Evaluate Drug-Drug Interactions (DDI) of JMKX003142 Tablets in Chinese Healthy Participants.

This is a single-center, non-randomized, open-label, self-controlled, Phase I clinical trial to evaluate the drug-drug interactions (DDI) of JMKX003142 tablets in healthy adult participants.

The study consists of five cohorts (Cohorts 1, 2, 3, 4, and 5). A total of 24 participants are planned enrollment in each of Cohorts 1, 2, 3, and 5, while 16 participants are planned for Cohort 4.

調査の概要

研究の種類

介入

入学 (推定)

112

段階

  • フェーズ 1

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:

  1. Participants are able to return to the study center for follow-up as required by the protocol and are willing to comply with study policies, procedures, and restrictions; capable of effective communication with the investigator and completing study-related materials; able to understand the contents of the Informed Consent Form (ICF) and sign the written ICF prior to any study procedures.
  2. Healthy Chinese male or female subjects, as determined by medical history and physical examination. At the time of signing the Informed Consent Form (ICF), aged 18-45 years (inclusive) ; body weight ≥ 50 kg for males or ≥ 45 kg for females; and Body Mass Index (BMI) within the range of 19.0-26.0 kg/m² (inclusive).
  3. Participants were considered healthy by the Investigator based on medical history, baseline physical examination, clinical laboratory assessments, and 12-lead ECG, with all results judged as normal or not clinically significant.
  4. Participants of childbearing potential who agree to use effective contraception and have no plans for conception, cryopreservation, or donation of gametes from ICF signature through 3 months after the last dose.

Exclusion Criteria:

  1. Known or suspected hypersensitivity to JMKX003142 (active ingredient or excipients), or a history of hypersensitivity to more than two drugs, foods, or other substances.
  2. History or presence of clinically significant diseases in any of the following systems (including but not limited to): cardiovascular, respiratory, gastrointestinal, hematologic, genitourinary, endocrine/metabolic, nervous, psychiatric, musculoskeletal, dermatologic, lymphatic, immune, or sensory organs; or current active local or systemic infection.
  3. Any condition increasing the risk of bleeding, such as acute gastritis, active ulcer with hemorrhage, clinically significant thrombocytopenia or anemia, active pathological bleeding, or a history of intracranial hemorrhage.
  4. Vital signs meet any of the following criteria at screening: systolic blood pressure ≥ 140 mmHg or < 90 mmHg; diastolic blood pressure ≥ 90 mmHg or < 50 mmHg; pulse rate > 100 bpm or < 50 bpm; or tympanic temperature ≥ 37.5°C or < 35°C.
  5. Subjects with a history of QTc interval prolongation or a family history of Long QT Syndrome; or those with clinically significant abnormal ECG findings as determined by the Investigator during screening; or a QTcF ≥ 450 ms; or a QRS interval > 120 ms.
  6. Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody, or syphilis serology.
  7. Treatment with therapeutic biological products within 3 months (or 5 half-lives, whichever is longer) prior to dosing, or other prescription/non-prescription medications (including vaccines, Traditional Chinese Medicine [TCM], dietary supplements, and health products) within 1 month (or 5 half-lives, whichever is longer).
  8. Use of any investigational drug within 3 months prior to screening, or current participation in another clinical trial.
  9. Major surgery (e.g., requiring general or epidural anesthesia) within 3 months prior to screening, or planned surgical intervention during the study.
  10. History of hemophobia, belonephobia, or difficult venous access.
  11. Blood donation or blood loss of ≥400 mL within 3 months prior to screening.
  12. History of drug dependence/abuse or illicit drug use, or a positive drug screening result.
  13. Smoking ≥5 cigarettes per day within 3 months prior to screening, or inability to commit to abstaining from tobacco products during the study, or a positive nicotine screening result.
  14. History of heavy alcohol consumption (>14 units per week; 1 unit ≈ 10 mL alcohol, equivalent to approx. 285 mL beer [3.5%], 25 mL spirits [40%], or 100 mL wine [10%]), inability to abstain from alcohol after screening, or a positive alcohol breath test.
  15. Daily consumption of excessive tea, coffee, or caffeine-containing beverages (more than 8 cups per day; 1 cup = 250 mL) within 14 days prior to screening.
  16. Ingestion of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos) or fruit products within 3 days prior to dosing.
  17. Special dietary requirements, or inability to comply with a standardized diet (e.g., standard meals) and dietary restrictions.
  18. Pregnancy or lactation, positive pregnancy test in females, unprotected sexual intercourse with a partner within 14 days prior to screening, use of oral contraceptives within 30 days prior to screening, or use of long-acting injectable or implanted estrogens/progestogens within 6 months prior to screening.
  19. Requirement to drive long distances, work at heights, or operate complex machinery during the study.
  20. Other conditions that, in the investigator's opinion, would make the subject unsuitable for participation in this study.

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: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:Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142
3mg once daily (QD) on Day 1 and Day 7
400mg QD on Day 4, 200mg QD from Day 5 to Day 9
6mg QD from Day 8 to Day 25
6mg QD on Day 1 and Day 8
6mg QD on Day 1 and Day 10
実験的:Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail Substrates
3mg once daily (QD) on Day 1 and Day 7
6mg QD from Day 8 to Day 25
6mg QD on Day 1 and Day 8
6mg QD on Day 1 and Day 10
Midazolam Oral Solution 2mg, Rosuvastatin Calcium Tablets 5mg and Digoxin Tablets 0.25mg QD on Day 1, Day 8 and Day 21
実験的:Cohort 3: To evaluate the effect of cyclosporine on the pharmacokinetic (PK) profile of JMKX003142
3mg once daily (QD) on Day 1 and Day 7
6mg QD from Day 8 to Day 25
6mg QD on Day 1 and Day 8
6mg QD on Day 1 and Day 10
100 mg twice daily (BID) from Day 4 to Day 9
実験的:Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142
3mg once daily (QD) on Day 1 and Day 7
6mg QD from Day 8 to Day 25
6mg QD on Day 1 and Day 8
6mg QD on Day 1 and Day 10
40mg QD from Day 4 to Day 8
実験的:Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142
3mg once daily (QD) on Day 1 and Day 7
6mg QD from Day 8 to Day 25
6mg QD on Day 1 and Day 8
6mg QD on Day 1 and Day 10
600mg QD from Day 4 to Day 12

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
Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites
時間枠:for 120 hours
for 120 hours
Area Under Curve (AUC) of JMKX003142 and its metabolites
時間枠:for 120 hours
for 120 hours
Maximum Plasma Concentration (Cmax) of Midazolam and its metabolites
時間枠:for 144 hours
for 144 hours
Area Under Curve (AUC) of of Midazolam and its metabolites
時間枠:for 144 hours
for 144 hours
Maximum Plasma Concentration (Cmax) of Rosuvastatin
時間枠:144 hours
144 hours
Area Under Curve (AUC) of of Rosuvastatin
時間枠:for 144 hours
for 144 hours
Maximum Plasma Concentration (Cmax) of Digoxin
時間枠:for 144 hours
for 144 hours
Area Under Curve (AUC) of Digoxin
時間枠:for 144 hours
for 144 hours

二次結果の測定

結果測定
時間枠
Tmax of JMKX003142 and its metabolites
時間枠:for 120 hours
for 120 hours
T1/2 of JMKX003142 and its metabolites
時間枠:for 120 hours
for 120 hours
CL of JMKX003142 and its metabolites
時間枠:for 120 hours
for 120 hours
Tmax of Midazolam and its metabolites
時間枠:for 144 hours
for 144 hours
T1/2 of Midazolam and its metabolites
時間枠:for 144 hours
for 144 hours
CL of Midazolam and its metabolites
時間枠:for 144 hours
for 144 hours
Tmax of Rosuvastatin
時間枠:for 144 hours
for 144 hours
T1/2 of Rosuvastatin
時間枠:for 144 hours
for 144 hours
CL of Rosuvastatin
時間枠:for 144 hours
for 144 hours
Tmax of Digoxin
時間枠:for 144 hours
for 144 hours
T1/2 of Digoxin
時間枠:for 144 hours
for 144 hours
CL of Digoxin
時間枠:for 144 hours
for 144 hours

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 (推定)

2026年5月11日

一次修了 (推定)

2026年11月15日

研究の完了 (推定)

2027年2月28日

試験登録日

最初に提出

2026年4月27日

QC基準を満たした最初の提出物

2026年4月27日

最初の投稿 (実際)

2026年5月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月4日

QC基準を満たした最後の更新が送信されました

2026年4月27日

最終確認日

2026年4月1日

詳しくは

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。

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