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

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-27

Study Completion Date

2022-01-12

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inhibitor group

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

Group Type EXPERIMENTAL

Jaktinib Hydrochloride Tablets

Intervention Type DRUG

Oral Jaktinib 100 mg for 1 day

Itraconazole capsule

Intervention Type DRUG

Oral Itraconazole 200 mg for 9 day

Inducer group

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.

Group Type EXPERIMENTAL

Jaktinib Hydrochloride Tablets

Intervention Type DRUG

Oral Jaktinib 100 mg for 1 day

Rifampicin Capsules

Intervention Type DRUG

Oral Rifampicin 600 mg for 11 day

Interventions

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Jaktinib Hydrochloride Tablets

Oral Jaktinib 100 mg for 1 day

Intervention Type DRUG

Itraconazole capsule

Oral Itraconazole 200 mg for 9 day

Intervention Type DRUG

Rifampicin Capsules

Oral Rifampicin 600 mg for 11 day

Intervention Type DRUG

Other Intervention Names

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Jaktinib Itraconazole Rifampicin

Eligibility Criteria

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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.;