A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-25

Study Completion Date

2024-02-20

Brief Summary

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This is a phase I study to evaluate drug-drug interactions (DDIs) of JAB-21822 as a perpetrator combined with midazolam , rosuvastatin, and digoxin and to evaluate DDIs of JAB-21822 as a victim combined with itraconazole， rifampicin， and omeprazole in healthy subjects.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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JAB-21822+Itraconazole

Group Type EXPERIMENTAL

JAB-21822

Intervention Type DRUG

JAB-21822 was administered orally

Itraconazole

Intervention Type DRUG

Itraconazole was administered orally

JAB-21822+ Rifampicin

Group Type EXPERIMENTAL

JAB-21822

Intervention Type DRUG

JAB-21822 was administered orally

Rifampicin

Intervention Type DRUG

Rifampicin was administered orally

JAB-21822+ Omeprazole

Group Type EXPERIMENTAL

JAB-21822

Intervention Type DRUG

JAB-21822 was administered orally

Omeprazole

Intervention Type DRUG

Omeprazole was administered orally

Dazolam , Rosuvastatin calcium and digoxin with JAB-21822

Group Type EXPERIMENTAL

JAB-21822

Intervention Type DRUG

JAB-21822 was administered orally

Midazolam , Rosuvastatin calcium and digoxin

Intervention Type DRUG

Midazolam , Rosuvastatin calcium and digoxin was administered orally

Interventions

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JAB-21822

JAB-21822 was administered orally

Intervention Type DRUG

Itraconazole

Itraconazole was administered orally

Intervention Type DRUG

Omeprazole

Omeprazole was administered orally

Intervention Type DRUG

Midazolam , Rosuvastatin calcium and digoxin

Midazolam , Rosuvastatin calcium and digoxin was administered orally

Intervention Type DRUG

Rifampicin

Rifampicin was administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female ；Healthy subjects aged 18 to 50 years (including both ends) at the time of signing informed consent
2. Male subjects weighed ≥50kg, female subjects weighed ≥45kg, body mass index (BMI) was between 19.0 and 26.0kg/m2, BMI= weight (kg)/height 2 (m2), including boundary values.
3. Subjects voluntarily signed written informed consent and were able to communicate well with the investigator

Exclusion Criteria

1. History of severe systemic diseases, history of liver and kidney insufficiency, history of mental illness, history of drug dependence;
2. Patients with a history of interstitial pneumonia, pulmonary fibrosis or other interstitial lung diseases who were not eligible for admission by the investigators;
3. Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, and have digestive diseases (such as peptic ulcer, pancreatitis, colitis, etc.) within 3 months before the first dose;
4. The investigator believes that the subject has any other circumstances that make him or her unfit to participate in this clinical trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes