Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules

NCT04675060 | Unknown Phase 1

• 1 other identifier: TQ-B3139-I-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to evaluate the effect of high-fat meal on the pharmacokinetics of TQ-B3139 capsules in patients with solid tumor

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• AUC0-t

  To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to time.

  0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.

• AUC0-∞

  To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to infinity.

  0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.

• Cmax

  Cmax is the maximum plasma concentration of TQ-B3139 or metabolite(s).

  0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.

Secondary Outcomes (6)

• Tmax

  0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.

• t1/2

  0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.

• Objective Response Rate (ORR)

  up to 24 months

• Progression-free survival (PFS)

  up to 24 months

• Disease control rate (DCR)

  up to 24 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

TQ-B3139 capsules administered single dose of 600 mg under fasted conditions in day 1 followed by single dose of 600 mg with a high-fat meal in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily.

Drug: TQ-B3139 capsules

Cohort 2

EXPERIMENTAL

TQ-B3139 capsules administered single dose of 600 mg with a high-fat meal in day 1 followed by single dose of 600 mg under fasted conditions in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily.

Drug: TQ-B3139 capsules

Interventions

TQ-B3139 capsules DRUG

TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
• \. Life expectancy ≥12 weeks. 3. Patients with confirmed gene mutations, including ALK fusion, ROS1 fusion, MET mutation or amplification.
• \. Adequate organ system function. 5.Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
• Understood and signed an informed consent form.

You may not qualify if:

• \. Has other malignancies within 3 years. 2. Has multiple factors affecting oral medication. 3. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(CTCAE 5.0) .
• \. Has received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose.
• \. Has long-term unhealed wounds or fractures. 6. Has a history of psychotropic drug abuse or have a mental disorder. 7. Has any severe and/or uncontrolled disease. 8. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks or 5 half-life of drug elimination (whichever comes first) before the first dose.
• \. Has participated in other clinical studies within 4 weeks before enrollment. 10.Using inhibitors or inducers of CYP3A at present. 11. Has receiving Chinese patent medicines with anti-tumor indications in the drug instructions that NMPA approved within 2 weeks before the start of the study treatment.
• \. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
• \. Brain metastases with symptoms or symptoms of brain metastases were controlled for less than 2 weeks.
• \. In lactation period or plan to breastfeed during the study period. 15.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

RECRUITING

Central Study Contacts

Nong Yang, Doctor

CONTACT

0731-89762320; yangnongpi@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: February 23, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 1, 2021

Record last verified: 2020-12

Locations

CN (1)