- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
- Droga: JMKX003142 tablets
- Droga: Fluconazole Capsules
- Droga: JMKX003142 tablets
- Droga: JMKX003142 tablets
- Droga: JMKX003142 tablets
- Droga: Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets)
- Droga: Cyclosporine Soft Capsules
- Droga: Omeprazole Enteric-coated Tablets
- Droga: Efavirenz Tablets
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites
Lasso di tempo: for 120 hours
|
for 120 hours
|
|
Area Under Curve (AUC) of JMKX003142 and its metabolites
Lasso di tempo: for 120 hours
|
for 120 hours
|
|
Maximum Plasma Concentration (Cmax) of Midazolam and its metabolites
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
Area Under Curve (AUC) of of Midazolam and its metabolites
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
Maximum Plasma Concentration (Cmax) of Rosuvastatin
Lasso di tempo: 144 hours
|
144 hours
|
|
Area Under Curve (AUC) of of Rosuvastatin
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
Maximum Plasma Concentration (Cmax) of Digoxin
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
Area Under Curve (AUC) of Digoxin
Lasso di tempo: for 144 hours
|
for 144 hours
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Tmax of JMKX003142 and its metabolites
Lasso di tempo: for 120 hours
|
for 120 hours
|
|
T1/2 of JMKX003142 and its metabolites
Lasso di tempo: for 120 hours
|
for 120 hours
|
|
CL of JMKX003142 and its metabolites
Lasso di tempo: for 120 hours
|
for 120 hours
|
|
Tmax of Midazolam and its metabolites
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
T1/2 of Midazolam and its metabolites
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
CL of Midazolam and its metabolites
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
Tmax of Rosuvastatin
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
T1/2 of Rosuvastatin
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
CL of Rosuvastatin
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
Tmax of Digoxin
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
T1/2 of Digoxin
Lasso di tempo: for 144 hours
|
for 144 hours
|
|
CL of Digoxin
Lasso di tempo: for 144 hours
|
for 144 hours
|
Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Ciliopatie
- Malattie urogenitali
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie genetiche, congenite
- Anomalie congenite
- Anomalie multiple
- Malattie renali, cistiche
- Malattie del rene policistico
- Malattie e anomalie congenite, ereditarie e neonatali
- Rene policistico, autosomica dominante
- Composti eterociclici, 1-anello
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Azoli
- Carboidrati
- Composti policiclici
- Glicosidi
- Steroidi
- Composti anelli fusi
- Benzazepine
- Benzodiazepine
- Triazoli
- Digitalis Glycosides
- Cardenolides
- Glicosidi cardiaci
- Cardanolidi
- Midazolam
- Digossina
- Fluconazolo
- Efavirenz
Altri numeri di identificazione dello studio
- JMKX003142-106
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su JMKX003142 tablets
-
JemincareNon ancora reclutamento
-
JemincareZhejiang Hangyu Pharmaceutical Co., LtdNon ancora reclutamento
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JemincareZhejiang Hangyu Pharmaceutical Co., Ltd.Non ancora reclutamentoADPKD (malattia renale policistica autosomica dominante)
-
JemincareZhejiang Hangyu Pharmaceutical Co., LtdReclutamento
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JemincareReclutamentoADPKD (malattia renale policistica autosomica dominante)Cina
-
JemincareZhejiang Hangyu Pharmaceutical Co., Ltd.Non ancora reclutamentoADPKD (malattia renale policistica autosomica dominante)
-
The Third Xiangya Hospital of Central South UniversityNon ancora reclutamentoMalattia di Charcot-Marie-Tooth (CMT)
-
Research Associates of New York, LLPCompletato
-
TakedaCompletatoMorbo di ParkinsonGiappone
-
JemincareReclutamentoEdema secondario | Edema GambaCina