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Drug-Drug Interactions of JMKX003142 in Healthy Participants

27. april 2026 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

112

Fase

  • Fase 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Eksperimentell: 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
Eksperimentell: 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
Eksperimentell: 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
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Tmax of JMKX003142 and its metabolites
Tidsramme: for 120 hours
for 120 hours
T1/2 of JMKX003142 and its metabolites
Tidsramme: for 120 hours
for 120 hours
CL of JMKX003142 and its metabolites
Tidsramme: for 120 hours
for 120 hours
Tmax of Midazolam and its metabolites
Tidsramme: for 144 hours
for 144 hours
T1/2 of Midazolam and its metabolites
Tidsramme: for 144 hours
for 144 hours
CL of Midazolam and its metabolites
Tidsramme: for 144 hours
for 144 hours
Tmax of Rosuvastatin
Tidsramme: for 144 hours
for 144 hours
T1/2 of Rosuvastatin
Tidsramme: for 144 hours
for 144 hours
CL of Rosuvastatin
Tidsramme: for 144 hours
for 144 hours
Tmax of Digoxin
Tidsramme: for 144 hours
for 144 hours
T1/2 of Digoxin
Tidsramme: for 144 hours
for 144 hours
CL of Digoxin
Tidsramme: for 144 hours
for 144 hours

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

11. mai 2026

Primær fullføring (Antatt)

15. november 2026

Studiet fullført (Antatt)

28. februar 2027

Datoer for studieregistrering

Først innsendt

27. april 2026

Først innsendt som oppfylte QC-kriteriene

27. april 2026

Først lagt ut (Faktiske)

4. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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