A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Jaktinib in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Jaktinib Hydrochloride Tablets; Drug: Itraconazole capsule; Drug: Rifampicin Capsules

• Registration Number: NCT06246695
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

The primary objective of this study was to assess the effect of rifampicin and itraconazole, on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-27
• Primary Completion: 2022-01-12
• Study Completion: 2022-01-12
• Status Verified: 2024-01
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy Volunteers aged between 18 and 45 years old;
• Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 28 (including 19 and 28);
• The participant is in good health and has no history of heart, liver, kidney, digestive tract, nervous system, etc.;

Exclusion Criteria

• The participant were deemed unsuitable for participating in the study by the investigator for any reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhibitor group	Jaktinib Hydrochloride Tablets	Jaktinib 100mg, once daily on the 1st and 9th days before meal; Itraconazole 200mg, once daily from the 4th day to the 12th day.
Inhibitor group	Itraconazole capsule	Jaktinib 100mg, once daily on the 1st and 9th days before meal; Itraconazole 200mg, once daily from the 4th day to the 12th day.
Inducer group	Jaktinib Hydrochloride Tablets	1. Jaktinib 100mg, once daily on the 1st and 12th days before meal, Rifampicin 600mg, once daily from the 4th day to the 14th day. 2. Rifampicin 600mg, once daily from the 1th day to the 11th day, Jaktinib 100mg, once daily on the 9st and 25th days before meal.
Inducer group	Rifampicin Capsules	1. Jaktinib 100mg, once daily on the 1st and 12th days before meal, Rifampicin 600mg, once daily from the 4th day to the 14th day. 2. Rifampicin 600mg, once daily from the 1th day to the 11th day, Jaktinib 100mg, once daily on the 9st and 25th days before meal.

Primary Outcome Measures

Name	Time	Method
Cmax	Up to 32 Days	Pharmacokinetics of Jaktinib by assessment of maximum plasma concentration
AUC	Up to 32 Days	Area under the plasma concentration versus time curve (AUC) of Jaktinib
Adverse Events	Up to 32 Days	Number of Participants With treatment-related Adverse Events and Serious Adverse Events

Trial Locations

Locations (1)

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China