New drug interaction study for myelofibrosis treatment begins
NCT ID NCT06024915
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 1 trial in 40 healthy adults tests how TQ05105, a drug for myelofibrosis, interacts with other medications that affect liver enzymes. Participants take TQ05105 alone and then with either itraconazole or rifampicin to see how these drugs change TQ05105 levels in the body. The goal is to understand safety and dosing for future use in patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TQ05105 tablets (a JAK2 inhibitor)
- What this could lead to
- If successful, this study could help doctors understand how to safely combine TQ05105 with other medications for myelofibrosis patients.
- What could go wrong
- This is a very early phase 1 study in healthy volunteers, not patients. It only tests drug interactions, not whether TQ05105 works for myelofibrosis. Results may not predict real-world outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
40 people
The number who actually took part.
- Started
-
Sep 2023
- Finished
-
May 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Myelofibrosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Half-Matched stem cells tested as cure for myelofibrosis
- Can blood tests predict transplant complications?
- Can a new daily pill shrink the spleen and ease myelofibrosis symptoms?
- Can a new pill tame myelofibrosis?
- MRI as a window into bone marrow disease: a new biomarker test?
- Can a menin inhibitor tame myelofibrosis when standard drugs fall short?