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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06246695
• Other study ID #: ZGJAK022
• Status: Completed
• Phase: Phase 1
• Start date: October 27, 2021
• Est. completion date: January 12, 2022

Study information

• Verified date: January 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 12, 2022
• Est. primary completion date: January 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Jaktinib Hydrochloride Tablets
Oral Jaktinib 100 mg for 1 day
• Itraconazole capsule
Oral Itraconazole 200 mg for 9 day
• Rifampicin Capsules
Oral Rifampicin 600 mg for 11 day

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Pharmacokinetics of Jaktinib by assessment of maximum plasma concentration	Up to 32 Days
Primary	AUC	Area under the plasma concentration versus time curve (AUC) of Jaktinib	Up to 32 Days
Primary	Adverse Events	Number of Participants With treatment-related Adverse Events and Serious Adverse Events	Up to 32 Days