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Chronic Myeloid Leukemia (CML)Phase 1NCT04126707

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

A Phase 1 study testing [14C] HQP1351 in people with Chronic Myeloid Leukemia (CML), run by Ascentage Pharma Group Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Chronic Myeloid Leukemia (CML)
What is being tested?
[14C] HQP1351
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
19 Nov 2019to 13 Jan 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • A subject will not be eligible for study participation if he meets any of the exclusion criteria:
  • 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
Show all 25Show fewer
  • 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;
  • History of drug or alcohol abuse;
  • 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;
  • Subject with mentally ill and could not understand the property, scope and possible consequences of the study;
  • subject in prison or whose freedom is restricted by administrative or legal issues;
  • Failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study;
  • Abnormal coagulation function or known severe bleeding tendency;
  • Subjects who have participated in radiolabeled clinical study prior to drug administration;
  • 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).
  • Investigators think that subjects are not suitable to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing

Other trials in China

About this study

Official title: A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C] HQP1351 After a Single Oral 30mg (100µCi) Dose in Healthy Chinese Male Subjects

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.

Being tested
[14C] HQP1351
Keywords
Chronic Myeloid Leukemia, HQP1351
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C] HQP1351Drug

    Orally, single dose of 30mg

Study groups in NCT04126707
Study groupRoleWhat they receive
[14C] HQP1351ExperimentalTo 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.
Receives: Drug: [14C] HQP1351

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radioactivity concentration of each blood and plasma sample

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

    Measured: Day 1- Day 15

  2. Radioactivity concentration of each urine samples

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

    Measured: Day 1- Day 15

  3. Radioactivity concentration of each feces samples

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

    Measured: Day 1- Day 15

  4. Total recovery of radioactivity in urine and feces

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

    Measured: Day 1- Day 15

Secondary outcomes (2)

  1. Plasma drug concentrations

    To determine the plasma concentrations of HQP1351 with validated LC-MS/MS method for obtaining its pharmacokinetics parameters

    Measured: Day 1- Day 15

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

    According to CTCAE v5.0, the number and frequency of adverse events after a single dose of test drug were assessed.

    Measured: Day 1- Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2019
  2. Study start19 Nov 2019
  3. Primary completion13 Jan 2020
  4. Study completion13 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04126707
Sponsor's protocol ID
HQP1351XC105
Status last verified
Jul 2020
First submitted
11 Oct 2019
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C] HQP1351 in people with Chronic Myeloid Leukemia (CML), run by Ascentage Pharma Group Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radioactivity concentration of each blood and plasma sample (time frame: Day 1- Day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04126707.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.

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