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A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets

Primary Purpose

Myelofibrosis

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQ05105 tablets
Itraconazole capsule
Rifampicin Capsule
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelofibrosis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: At the time of signing the informed consent, males or females between 18 and 45 years of age; Female weight ≥ 45 kg, male weight ≥ 50 kg, with a body mass index (BMI) between 19 and 26 kg/m2. Subjects in good health, as determined by a medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations; Subjects can comply with the study procedures, voluntarily participate in the study, and sign the informed consent in person. Exclusion Criteria: Subjects: preexisting or existing circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic disorders or abnormalities, or related chronic or acute diseases, the investigator assesses that it is not appropriate to participate in the trial; Subjects with Systemic/local acute infection before taking the study drug; Subjects who have a history of specific allergies, or allergic conditions (such as allergies to two or more drugs, environments, or foods), or are known to be allergic to components or analogs of the study drug; Subjects who have difficulty in swallowing or have any gastrointestinal disorder that affects drug absorption at the time of screening; Subjects who cannot receive venous indwelling needle for blood sample collection; Subjects who drank regularly in the 6 months prior to first dosing, such as those who drank more than 14 units of alcohol per week or who had a positive alcohol breath test at the time of screening; Subjects who had a history of major surgery, or had taken the study drug, or had participated in other drug clinical trials within 3 months prior to initial dosing; Subjects who donated blood or lost significant amounts of blood within 3 months prior to initial dosing; Subjects who had used drugs within 3 months prior to first dosing, or tested positive for drugs, or had a history of drug abuse within 5 years prior to screening; Subjects who smoked more than 5 cigarettes per day in the 3 months prior to initial dosing or who could not stop using any tobacco products during the trial; Subjects who consumed excessive amounts of tea, coffee, and/or caffeinated beverages daily in the 30 days prior to initial dosing; Subjects who have used any drug that inhibits or induces liver metabolism of the drug in the 30 days prior to initial dosing; Subjects who have taken any prescription, over-the-counter, herbal, or health product in the 14 days prior to initial dosing; Subjects who have taken a special diet or other factors affecting drug absorption, distribution, metabolism, or excretion within 7 days prior to initial dosing; Subjects who ingested chocolate, any caffeinated, or xanthine-rich food or drink 48 hours before first dosing; Subjects who have special dietary requirements and cannot follow a uniform diet; Female subjects of child-bearing potential; Subjects judged by the investigator to be unsuitable to participate.

Sites / Locations

  • Shandong Provincial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Itraconazole drug-durg interaction (DDI)

Rifampicin DDI

Arm Description

Itraconazole capsule: 0.2g once daily on Days 2 to Day 5; TQ05105 tablets: single oral dose on Days 1 and Day 5.

Rifampicin Capsule: 0.6g once daily on Days 2 to Day 9; TQ05105 tablets: single oral dose on Days 1 and Day 9.

Outcomes

Primary Outcome Measures

Maximum plasma concentration (Cmax)
Maximum plasma drug concentration after administration.
Time to reach Cmax (Tmax)
Time to reach the maximum plasma concentration after administration.
Elimination half-life (t1/2)
The elimination half-life (t1/2) after oral dose of TQ05105 tablets and Itraconazole capsule.

Secondary Outcome Measures

Occurrence of adverse events (AE)
Including all adverse events (AE) and serious adverse events (SAE).

Full Information

First Posted
August 30, 2023
Last Updated
August 30, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06024915
Brief Title
A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets
Official Title
A Phase I Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of metabolic enzyme inhibitors/inducers on in vivo metabolic and elimination of TQ05105 tablets, and the safety of metabolic enzyme inhibitors/inducers combined with TQ05105 tablets.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Itraconazole drug-durg interaction (DDI)
Arm Type
Experimental
Arm Description
Itraconazole capsule: 0.2g once daily on Days 2 to Day 5; TQ05105 tablets: single oral dose on Days 1 and Day 5.
Arm Title
Rifampicin DDI
Arm Type
Experimental
Arm Description
Rifampicin Capsule: 0.6g once daily on Days 2 to Day 9; TQ05105 tablets: single oral dose on Days 1 and Day 9.
Intervention Type
Drug
Intervention Name(s)
TQ05105 tablets
Intervention Description
TQ05105 is a Janus kinase 2 (JAK2) inhibitor.
Intervention Type
Drug
Intervention Name(s)
Itraconazole capsule
Intervention Description
Itraconazole is a strong inhibitor of cytochrome P450 3A (CYP3A).
Intervention Type
Drug
Intervention Name(s)
Rifampicin Capsule
Intervention Description
Rifampicin is a strong inducer of CYP3A.
Primary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Description
Maximum plasma drug concentration after administration.
Time Frame
Up to 10 days.
Title
Time to reach Cmax (Tmax)
Description
Time to reach the maximum plasma concentration after administration.
Time Frame
Up to 10 days.
Title
Elimination half-life (t1/2)
Description
The elimination half-life (t1/2) after oral dose of TQ05105 tablets and Itraconazole capsule.
Time Frame
Up to 6 days.
Secondary Outcome Measure Information:
Title
Occurrence of adverse events (AE)
Description
Including all adverse events (AE) and serious adverse events (SAE).
Time Frame
Up to 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At the time of signing the informed consent, males or females between 18 and 45 years of age; Female weight ≥ 45 kg, male weight ≥ 50 kg, with a body mass index (BMI) between 19 and 26 kg/m2. Subjects in good health, as determined by a medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations; Subjects can comply with the study procedures, voluntarily participate in the study, and sign the informed consent in person. Exclusion Criteria: Subjects: preexisting or existing circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic disorders or abnormalities, or related chronic or acute diseases, the investigator assesses that it is not appropriate to participate in the trial; Subjects with Systemic/local acute infection before taking the study drug; Subjects who have a history of specific allergies, or allergic conditions (such as allergies to two or more drugs, environments, or foods), or are known to be allergic to components or analogs of the study drug; Subjects who have difficulty in swallowing or have any gastrointestinal disorder that affects drug absorption at the time of screening; Subjects who cannot receive venous indwelling needle for blood sample collection; Subjects who drank regularly in the 6 months prior to first dosing, such as those who drank more than 14 units of alcohol per week or who had a positive alcohol breath test at the time of screening; Subjects who had a history of major surgery, or had taken the study drug, or had participated in other drug clinical trials within 3 months prior to initial dosing; Subjects who donated blood or lost significant amounts of blood within 3 months prior to initial dosing; Subjects who had used drugs within 3 months prior to first dosing, or tested positive for drugs, or had a history of drug abuse within 5 years prior to screening; Subjects who smoked more than 5 cigarettes per day in the 3 months prior to initial dosing or who could not stop using any tobacco products during the trial; Subjects who consumed excessive amounts of tea, coffee, and/or caffeinated beverages daily in the 30 days prior to initial dosing; Subjects who have used any drug that inhibits or induces liver metabolism of the drug in the 30 days prior to initial dosing; Subjects who have taken any prescription, over-the-counter, herbal, or health product in the 14 days prior to initial dosing; Subjects who have taken a special diet or other factors affecting drug absorption, distribution, metabolism, or excretion within 7 days prior to initial dosing; Subjects who ingested chocolate, any caffeinated, or xanthine-rich food or drink 48 hours before first dosing; Subjects who have special dietary requirements and cannot follow a uniform diet; Female subjects of child-bearing potential; Subjects judged by the investigator to be unsuitable to participate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang, MD, PhD
Phone
86-0531-68778331
Email
xinw007@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Ding, MD, PhD
Phone
+86 13864151105
Email
dingmei1105@sina.com
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD, PhD
Phone
86-0531-68778331
Email
xinw007@126.com

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets

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