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OpenTrials
Completed

NCT Number: NCT06246695

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Jaktinib Hydrochloride Tablets

Drug

Oral Jaktinib 100 mg for 1 day

Other names: Jaktinib

Itraconazole capsule

Drug

Oral Itraconazole 200 mg for 9 day

Other names: Itraconazole

Rifampicin Capsules

Drug

Oral Rifampicin 600 mg for 11 day

Other names: Rifampicin

Primary outcomes

  1. Cmax

    Time frame: Up to 32 Days

    Pharmacokinetics of Jaktinib by assessment of maximum plasma concentration

  2. AUC

    Time frame: Up to 32 Days

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

  3. Adverse Events

    Time frame: Up to 32 Days

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

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2024
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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