NCT06165822

Brief Summary

This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of Itraconazole Capsules/Rifampicin Capsules on pharmacokinetics of TQB3909 tablets in vivo, and the safety of TQB3909 tablets and combined with Itraconazole Capsules/Rifampicin Capsules after single oral dose.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 12, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

November 30, 2023

Last Update Submit

December 4, 2023

Conditions

Advanced Malignant Neoplasm

Keywords

Drug drug interaction

Outcome Measures

Primary Outcomes (3)

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time to reach maximum (peak) plasma concentration following drug administration.

    Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.

  • Maximum Plasma Concentration (Cmax)

    The maximum observed plasma concentration of TQB3909

    Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.

  • Elimination half-life (t1/2)

    The time required for half of the drug to be eliminated from the plasma.

    Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.

Secondary Outcomes (1)

  • Incidence of adverse events (AEs)

    Up to 12 days.

Study Arms (2)

Itraconazole drug-durg interaction (DDI)

EXPERIMENTAL

Itraconazole capsules, 0.2g once daily from Day 3 to Day 10 TQB3909 tablets, single oral dose on Day 1 and Day 8.

Drug: TQB3909 tabletsDrug: Itraconazole capsule

Rifampicin DDI

EXPERIMENTAL

Rifampicin capsule, 0.6g once daily from Day 3 to Day 11. TQB3909 tablets, single oral dose on Day 1 and Day 10.

Drug: TQB3909 tabletsDrug: Rifampicin capsule

Interventions

TQB3909 tabletsDRUG

TQB3909 100mg/tablet.

Itraconazole drug-durg interaction (DDI)Rifampicin DDI
Itraconazole capsuleDRUG

Itraconazole capsule is a strong inhibitor of CYP3A4.

Itraconazole drug-durg interaction (DDI)
Rifampicin capsuleDRUG

Rifampicin capsule is a strong inducer of CYP3A4.

Rifampicin DDI

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At the time of signing the informed consent, males or females of 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.

You may not qualify if:

  • Subjects: pre-existing or existing circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic disorders mental diseases or abnormalities, or related chronic or acute diseases, which were not appropriate to participate in the trial as assessed by the investigators ;
  • Subjects with systemic/local acute infection presented before study drug administration;
  • Subjects who have a history of specific allergies, or allergies;
  • 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 cannot tolerate venous puncture or have a history of needle or blood sickness;
  • Subjects who drank regularly within the 6 months prior to the 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, had taken the study drug, or had participated in other drug clinical trials within 3 months prior to the first dosing；
  • Subjects who donated blood or lost significant amounts of blood within 3 months prior to the first dosing；
  • Subjects who had used drugs within 3 months prior to the 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 within the 3 months prior to the first 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 within the 30 days prior to the first dosing；
  • Subjects who have used any drug that inhibits or induces liver metabolism of the drug within the 30 days prior to the first dosing；
  • Subjects who have taken any prescription, over-the-counter, herbal, or health product within the 14 days prior to the first dosing；
  • Subjects who have taken a special diet or other factors affecting drug absorption, distribution, metabolism, or excretion within 7 days prior to the first dosing；
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213004, China

Location

MeSH Terms

Interventions

ItraconazoleRifampin

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Central Study Contacts

Fei Hua, MD, PhD

CONTACT

0519-68870002czyyphase1@163.com

Weiying Gu, MD, PhD

CONTACT

0519-68871092guweiying2001@163.com

Study Design

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

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 12, 2023

Study Start

December 1, 2023

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

December 12, 2023

Record last verified: 2023-11

Locations

CN(1)