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Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects

a Single-center, Non-randomized, Open-label, Self-controlled Phase 1 Clinical Study to Evaluate Drug-drug Interactions of JMKX001899 Tablets in Healthy Subjects

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06348290
Enrollment
72
Registered
2024-04-04
Start date
2024-04-01
Completion date
2024-09-15
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor, Adult

Brief summary

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.

Interventions

DRUGJMKX001899

Oral

DRUGItraconazole

Oral

DRUGMidazolam

Oral

DRUGRifampin

Oral

DRUGdextromethorphan

Oral

DRUGRosuvastatin

Oral

DRUGdigoxin

Oral

Sponsors

Jemincare
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1. voluntarily sign the informed consent, fully understand the content of the trial, and be able to complete the study according to the requirements of the trial protocol. 2. subjects aged 18 to 45 years (including both ends) at the time of signing informed consent. 3. male body weight is not less than 50 kg, female body weight is not less than 50 kg, and body mass index (BMI) is within the range of 19 \ 27 kg/m2 (including cut-off value).

Exclusion criteria

1. hepatitis B surface antigen HBsAg positive, hepatitis C virus antibody positive, positive AIDS antigen/antibody or Treponema pallidum antibody. 2. Patients with a history of clinically significant diseases including, but not limited to, gastrointestinal, renal, liver, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, epilepsy, bipolar disorder/mania, intraocular hypertension, or acute angle-closure glaucoma. 3. have taken any products containing caffeine, alcohol, grapefruit, and xanthine-rich within 24 hours before taking study medication.

Design outcomes

Primary

MeasureTime frame
maximum concentrations (Cmax ) for plasmaapproximately 3 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for plasmaapproximately 3 days after first dose
area under the curve from time 0 to the last time point (AUC0-t) for plasmaapproximately 3 days after first dose

Contacts

Primary ContactJING XU
xujing2@jemincare.com+86-021-52887926

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026