The Absorption, Metabolism and Excretion of [14C] HQP1351 in Humans

NCT ID: NCT04126707

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2020-01-13

Brief Summary

The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 30mg (100µCi) dose of [14C] HQP1351 given as a suspension. For further clinical development, human mass balance data are required to elucidate the absorption, metabolism, and excretion of HQP1351.

Conditions

Chronic Myeloid Leukemia (CML)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[14C] HQP1351

To investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose (30mg, 100µCi) of \[14C\] HQP1351 to healthy Chinese male subjects.

Group Type: EXPERIMENTAL

[14C] HQP1351

Intervention Type: DRUG

Orally, single dose of 30mg

Interventions

[14C] HQP1351

Orally, single dose of 30mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

A subject will be eligible for study participation if he meets the following criteria:

1. Healthy male volunteers between the ages of 18 to 50 years old, inclusive;

2. Body weight >=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive);

3. Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;

4. Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 1 year after discontinuing treatment with the investigational product.

5. Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.

Exclusion Criteria

1. History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;

2. Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody;

3. Abnormality in blood pressure, including hypertensive BP (SBP>=140 mmHg, or DBP >=90 mmHg), or hypotensive BP (SBP<90 mmHg, or DBP <=55 mmHg), Pulse rate<55 bpm or >100 bpm;

4. Long-QT syndrome or family history of it, or QTcB interval > 450 ms; intraventricular blocks or left/right bundle branch block or QRS>120ms; frequent ventricular ectopic beats (any 10s ECG ventricular premature beat >= 1 in screening period); or abnormal resting heart rate (> 100 bpm)

5. The following abnormal clinical laboratory values

1. HGB < LLN or HGB>ULN, and is judged as clinically significant by the investigator；

2. Abnormal ALB, TP, CRE, ALT, AST, BIL, BUN, GLU value, and is judged as clinically significant by the investigator;

6. Received any drug within 14 days before taking the investigational drug, including any prescription drug, OTC drug, herbal drug or health care product with medicinal effect;

7. Received any other investigating products or participated in any clinical trails three month before screening or within 10 t1/2 after receiving other investigating products;

8. History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs;

9. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease or history of gastrointestinal surgery and cholecystectomy;

10. Hemorrhoids or perianal disease with regular/perianal bleeding;

11. Allergies, have allergies to two or more drugs or foods; or have known allergies to the components of the drug (microcrystalline cellulose, stearic acid, croscarmellose sodium);

12. Have donated 400ml or more of blood or plasma 3 months prior to the study drug administration, or more than 50ml within 2 weeks prior to administration;

13. Vaccination was administered within 6 months prior to screening or during screening;

14. History of drug or alcohol abuse;

15. Smoking (> 10 cigarette / day), drinking (> 15 g, pure alcohol / day, equivalent to 450 ml beer, 150 ml wine or 50 ml low-alcohol liquor), or abusing drugs within last 3 months;

16. Subject with mentally ill and could not understand the property, scope and possible consequences of the study;

17. subject in prison or whose freedom is restricted by administrative or legal issues;

18. Failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study;

19. Abnormal coagulation function or known severe bleeding tendency;

20. Subjects who have participated in radiolabeled clinical study prior to drug administration;

21. Significant radiation exposure within one year prior to drug administration (more than one exposure from chest X-ray, CT scan, or barium meal examination and radiation-related occupations).

22. Investigators think that subjects are not suitable to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

HealthQuest Pharma Inc.

INDUSTRY

Sponsor Role: collaborator

Ascentage Pharma Group Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Feng Shao, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital with Nanjing Medical University

Nanjing, , China

Countries

China

Other Identifiers

HQP1351XC105

Identifier Type: -

Identifier Source: org_study_id