Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions

Myelofibrosis Clinical Trial

Official title:

A Single-dose, Randomized, Open-label, Repeated Cross-over Pharmacokinetic Comparison Study of Two Formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers Under Fasted Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06132243
• Other study ID #: ZGJAK037
• Status: Completed
• Phase: Phase 1
• Start date: November 29, 2023
• Est. completion date: December 20, 2023

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

To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 18= age = 45, male or female;
• Body weight: =50 kg for male, =45 kg for female; body mass index (BMI): 19.0-26.0 kg/m^2 (inclusive);
• Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the trial will be fully understood;
• The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.

Exclusion Criteria:

• Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug;
• Participants with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and still clinically relevant according to the investigator;
• Participants with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic system and other diseases that require medical intervention or are not suitable for clinical trial (such as psychiatric history);
• With positive alcohol breath test;
• Volunteers may not be able to complete the study for other reasons or have other reasons for not participating in the study as judged by the investigator.

Related Conditions & MeSH terms

• Myelofibrosis
• Primary Myelofibrosis

Intervention

Drug:
• Jaktinib Hydrochloride Tablets
Orally, one tablet at a time

Locations

Country	Name	City	State
China	The Third Hospital of Changsha	Changsha	Hunan

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	Maximum Plasma Concentration (Cmax) Of Jaktinib and its main metabolite ZG0244	Maximum Plasma Concentration (Cmax)	up to 48 hours
Primary	Jaktinib and its main metabolite ZG0244 AUC(0-t)	Area under the concentration time curve from time 0 to time of the last quantifiable	up to 48 hours
Primary	Jaktinib and its main metabolite ZG0244 AUC(0-inf)	Area under the concentration time curve from time 0 to infinity	up to 48 hours
Secondary	Jaktinib and its main metabolite ZG0244 Tmax	Maximum Plasma Concentration (Tmax)	up to 48 hours
Secondary	Jaktinib and its main metabolite ZG0244 t1/2	Half Life (t1/2)	up to 48 hours
Secondary	Adverse events		Day 1 to Day 12