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

Healthy Subjects Clinical Trial

Official title:

A Single-center, Non-randomized, Open-lable, Self-controlled Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162169
• Other study ID #: JAB-21822-1010
• Status: Recruiting
• Phase: Phase 1
• Start date: November 25, 2023
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: Jacobio Pharmaceuticals
• Phone: 86 10 56315466
• Email: clinicaltrials[@]jacobiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• JAB-21822
JAB-21822 was administered orally
• Itraconazole
Itraconazole was administered orally
• Omeprazole
Omeprazole was administered orally
• Midazolam , Rosuvastatin calcium and digoxin
Midazolam , Rosuvastatin calcium and digoxin was administered orally
• Rifampicin
Rifampicin was administered orally

Locations

Country	Name	City	State
China	Beijing GoBroad Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed maximum concentrations (Cmax )of JAB-21822		approximately 10 days
Primary	Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822		approximately 10 days
Primary	Area under the concentration versus time curve from dose to infinity (AUC0-8) of JAB-21822		approximately 10 days
Primary	Observed maximum concentrations (Cmax )of midazolam, rosuvastatin, and digoxin		approximately 10 days
Primary	Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of midazolam, rosuvastatin, and digoxin		approximately 10 days
Primary	Area under the concentration versus time curve from dose to infinity (AUC0-8) of midazolam, rosuvastatin, and digoxin		approximately 10 days