- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07565441
Drug-Drug Interactions of JMKX003142 in Healthy Participants
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.
Studieöversikt
Status
Intervention / Behandling
- Läkemedel: JMKX003142 tablets
- Läkemedel: Fluconazole Capsules
- Läkemedel: JMKX003142 tablets
- Läkemedel: JMKX003142 tablets
- Läkemedel: JMKX003142 tablets
- Läkemedel: Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets)
- Läkemedel: Cyclosporine Soft Capsules
- Läkemedel: Omeprazole Enteric-coated Tablets
- Läkemedel: Efavirenz Tablets
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 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.
- 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).
- 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.
- 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:
- Known or suspected hypersensitivity to JMKX003142 (active ingredient or excipients), or a history of hypersensitivity to more than two drugs, foods, or other substances.
- 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.
- 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.
- 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.
- 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.
- Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody, or syphilis serology.
- 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).
- Use of any investigational drug within 3 months prior to screening, or current participation in another clinical trial.
- Major surgery (e.g., requiring general or epidural anesthesia) within 3 months prior to screening, or planned surgical intervention during the study.
- History of hemophobia, belonephobia, or difficult venous access.
- Blood donation or blood loss of ≥400 mL within 3 months prior to screening.
- History of drug dependence/abuse or illicit drug use, or a positive drug screening result.
- 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.
- 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.
- 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.
- Ingestion of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos) or fruit products within 3 days prior to dosing.
- Special dietary requirements, or inability to comply with a standardized diet (e.g., standard meals) and dietary restrictions.
- 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.
- Requirement to drive long distances, work at heights, or operate complex machinery during the study.
- Other conditions that, in the investigator's opinion, would make the subject unsuitable for participation in this study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites
Tidsram: for 120 hours
|
for 120 hours
|
|
Area Under Curve (AUC) of JMKX003142 and its metabolites
Tidsram: for 120 hours
|
for 120 hours
|
|
Maximum Plasma Concentration (Cmax) of Midazolam and its metabolites
Tidsram: for 144 hours
|
for 144 hours
|
|
Area Under Curve (AUC) of of Midazolam and its metabolites
Tidsram: for 144 hours
|
for 144 hours
|
|
Maximum Plasma Concentration (Cmax) of Rosuvastatin
Tidsram: 144 hours
|
144 hours
|
|
Area Under Curve (AUC) of of Rosuvastatin
Tidsram: for 144 hours
|
for 144 hours
|
|
Maximum Plasma Concentration (Cmax) of Digoxin
Tidsram: for 144 hours
|
for 144 hours
|
|
Area Under Curve (AUC) of Digoxin
Tidsram: for 144 hours
|
for 144 hours
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Tmax of JMKX003142 and its metabolites
Tidsram: for 120 hours
|
for 120 hours
|
|
T1/2 of JMKX003142 and its metabolites
Tidsram: for 120 hours
|
for 120 hours
|
|
CL of JMKX003142 and its metabolites
Tidsram: for 120 hours
|
for 120 hours
|
|
Tmax of Midazolam and its metabolites
Tidsram: for 144 hours
|
for 144 hours
|
|
T1/2 of Midazolam and its metabolites
Tidsram: for 144 hours
|
for 144 hours
|
|
CL of Midazolam and its metabolites
Tidsram: for 144 hours
|
for 144 hours
|
|
Tmax of Rosuvastatin
Tidsram: for 144 hours
|
for 144 hours
|
|
T1/2 of Rosuvastatin
Tidsram: for 144 hours
|
for 144 hours
|
|
CL of Rosuvastatin
Tidsram: for 144 hours
|
for 144 hours
|
|
Tmax of Digoxin
Tidsram: for 144 hours
|
for 144 hours
|
|
T1/2 of Digoxin
Tidsram: for 144 hours
|
for 144 hours
|
|
CL of Digoxin
Tidsram: for 144 hours
|
for 144 hours
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Ciliopatier
- Urogenitala sjukdomar
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Genetiska sjukdomar, medfödda
- Medfödda abnormiteter
- Avvikelser, flera
- Njursjukdomar, cystisk
- Polycystiska njursjukdomar
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Polycystisk njure, autosomal dominant
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Heterocykliska föreningar, 2-ring
- Heterocykliska föreningar, smältring
- Azoler
- Kolhydrater
- Polycykliska föreningar
- Glykosider
- Steroider
- Fusion-ringföreningar
- Benzazepiner
- Bensodiazepiner
- Triazoler
- Digitalis glykosider
- Gardenolider
- Hjärtglykosider
- Kardanolider
- Midazolam
- Digoxin
- Flukonazol
- efavirenz
Andra studie-ID-nummer
- JMKX003142-106
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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