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

NCT04126707 | Completed Phase 1

• 1 other identifier: HQP1351XC105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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)

Keywords

Chronic Myeloid Leukemia; HQP1351

Outcome Measures

Primary Outcomes (4)

• Radioactivity concentration of each blood and plasma sample

  Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample

  Day 1- Day 15

• Radioactivity concentration of each urine samples

  Use liquid scintillation counter to evaluate Radioactivity concentration of each urine sample

  Day 1- Day 15

• Radioactivity concentration of each feces samples

  Use liquid scintillation counter to evaluate Radioactivity concentration of each feces sample

  Day 1- Day 15

• Total recovery of radioactivity in urine and feces

  Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample

  Day 1- Day 15

Secondary Outcomes (2)

• Plasma drug concentrations

  Day 1- Day 15

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Day 1- Day 15

Study Arms (1)

[14C] HQP1351

EXPERIMENTAL

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.

Drug: [14C] HQP1351

Interventions

[14C] HQP1351 DRUG

Orally, single dose of 30mg

[14C] HQP1351

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A subject will be eligible for study participation if he meets the following criteria:
• Healthy male volunteers between the ages of 18 to 50 years old, inclusive;
• Body weight \>=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive);
• Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;
• 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.
• Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.

You may not qualify if:

• History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
• Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody;
• 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;
• 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)
• The following abnormal clinical laboratory values
• HGB \< LLN or HGB\>ULN, and is judged as clinically significant by the investigator；
• Abnormal ALB, TP, CRE, ALT, AST, BIL, BUN, GLU value, and is judged as clinically significant by the investigator;
• 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;
• 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;
• History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs;
• Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease or history of gastrointestinal surgery and cholecystectomy;
• Hemorrhoids or perianal disease with regular/perianal bleeding;
• 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);
• 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;
• Vaccination was administered within 6 months prior to screening or during screening;

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead
• HealthQuest Pharma Inc.: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, China

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

olverembatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Feng Shao, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: November 19, 2019
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: September 8, 2021

Record last verified: 2020-07

Locations

CN (1)