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

Zelgen Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Jaktinib Hydrochloride Tablets; Drug: Rifampicin Capsules; Drug: Itraconazole capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT06246695

ZGJAK022

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Inhibitor group

Experimental group

Description:

Jaktinib 100mg, once daily on the 1st and 9th days before meal; Itraconazole 200mg, once daily from the 4th day to the 12th day.

Treatment:

Drug: Itraconazole capsule

Drug: Jaktinib Hydrochloride Tablets

Inducer group

Experimental group

Description:

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.

Treatment:

Drug: Rifampicin Capsules

Drug: Jaktinib Hydrochloride Tablets