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

NCT06246695 | Completed Phase 1

• 1 other identifier: ZGJAK022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Cmax

  Pharmacokinetics of Jaktinib by assessment of maximum plasma concentration

  Up to 32 Days

• AUC

  Area under the plasma concentration versus time curve (AUC) of Jaktinib

  Up to 32 Days

• Adverse Events

  Number of Participants With treatment-related Adverse Events and Serious Adverse Events

  Up to 32 Days

Study Arms (2)

Inhibitor group

EXPERIMENTAL

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

Drug: Jaktinib Hydrochloride Tablets; Drug: Itraconazole capsule

Inducer group

EXPERIMENTAL

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.

Drug: Jaktinib Hydrochloride Tablets; Drug: Rifampicin Capsules

Interventions

Jaktinib Hydrochloride Tablets DRUG

Oral Jaktinib 100 mg for 1 day

Also known as: Jaktinib

Inducer group; Inhibitor group

Itraconazole capsule DRUG

Oral Itraconazole 200 mg for 9 day

Also known as: Itraconazole

Inhibitor group

Rifampicin Capsules DRUG

Oral Rifampicin 600 mg for 11 day

Also known as: Rifampicin

Inducer group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.;

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

MeSH Terms

Interventions

Itraconazole; Rifampin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: October 27, 2021
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)