A Phase 1 interventional study of JMKX001899 and Itraconazole in Solid Tumor, Adult, sponsored by Jemincare. Not yet recruiting. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Jemincare · Phase 1, Interventional, and Treatment
This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort.
Jemincare is the lead sponsor of 36 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enrolled subjects were treated with JMKX001899 on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 4 to Day 6. JMKX001899 and itraconazole were administered simultaneously after a standardized meal on Day 7. On Day 8 to Day 9, itraconazole was orally administered once after a standard meal
Drug: JMKX001899 · Drug: Itraconazole
Enrolled subjects were treated with JMKX001899 after high fat meal on Day 1 and an empty stomach on Day 4. Rifampin was administered orally once daily on an empty stomac from Day 7 to Day 15, Day 17and Day 18. JMKX001899 and Rigampin were administered simultaneously on an empty stomach on Day 16.
Drug: JMKX001899 · Drug: Rifampin
Enrolled subjects were treated with Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) on an empty stomach on Day 1. JMKX001899 was administered orally once daily after a standardized meal from Day 9 to Day 20 and Day 22. Cocktail and JMKX001899 were administered simultaneously on an empty stomach on Day 8 and Day 21.
Drug: JMKX001899 · Drug: Midazolam · Drug: dextromethorphan · Drug: Rosuvastatin · Drug: digoxin
Oral
Oral
Oral
Oral
Oral
Oral
Oral
maximum concentrations (Cmax ) for plasma
Time frame: approximately 3 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for plasma
Time frame: approximately 3 days after first dose
area under the curve from time 0 to the last time point (AUC0-t) for plasma
Time frame: approximately 3 days after first dose
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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