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Advanced or Metastatic Non-small Cell LungPhase 1NCT04464551

The Absorption, Metabolism and Excretion of [14C]D-0316 in Human

A Phase 1 study testing [14C]D-0316 suspension in people with Advanced or Metastatic Non-small Cell Lung, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] D-0316 in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the completion date of… Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
What is being tested?
[14C]D-0316 suspension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteChina
Study dates
5 Dec 2020to Aug 2021
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

  • healthy male volunteers between the ages of 18 to 50 years old；
  • Body weight >=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2；
  • 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. Highly effective methods of birth control include using condom, contraceptive sponge, contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptive pill, hypodermic implants or others；
  • Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.

Who cannot join

  • 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;
  • History of syncope / needle syncope and intolerable intravenous indwelling needle;
  • History of clinically significant disease or infection within 1 month before entering the study;
  • 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);
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  • Received any drug within 14 days before taking the investigational drug, including any prescription drug, OTC drug, herbal drug or health care products, except for vitamins and paracetamol；
  • 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;
  • 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;
  • Participated in other clinical trials within 3 months before screening;
  • The subjects participated in the clinical trial of radioactive labeling within one year before taking the medicine;
  • 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);

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine

    Nanjing, Jiangsu, 210029

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]D-0316 After a Single Oral 75mg/50µCi Dose in Healthy Chinese Male Subjects

This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] D-0316 in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the completion date of plasma, urine and feces sampling on the 3rd day post-dose and onwards. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 2-4 subjects will be adjusted according to the pilot study

Read the detailed description

Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning of Day 1 before dosing, subjects will be transferred to nuclear medical ward. And after an overnight fast of at least 10 h, subjects will receive a single oral dose of 75 mg (50 μCi) of [14C]D-0316 as an oral suspension. Then, after two days of the dosing, subjects will be transferred back to Phase I Clinical Unit ward and confined to this unit until blood or excreta sampling and safety monitoring at the designated time points or intervals are complete

Being tested
[14C]D-0316 suspension

What participants receive

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

  • [14C]D-0316 suspensionDrug

    Before administration, the drug preparation was placed at room temperature, and 40ml drinking water was added into each bottle to prepare suspension for the subjects to take. 40ml pure water was injected again. After washing the container, the subjects took orally. Repeat the previous step, and then used 160ml purified water. After the administration container was moistened for several times, the subjects took all the moistening lotion. Pay attention not to splash the liquid during mixing outside the bottle

Study groups in NCT04464551
Study groupRoleWhat they receive
[14C]D-0316ExperimentalTo investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose (75mg, 50µCi) of [14C]D-0316 to healthy Chinese male subjects
Receives: Drug: [14C]D-0316 suspension

What is being measured

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

  1. Radioactivity concentration of each plasma sample

    Use liquid scintillation counter or accelerator mass spectrometry to evaluate radioactivity concentration of each plasma（DPM/ml) sample

    Measured: Day 1-Day85

  2. Radioactivity concentration of each urine samples

    Use liquid scintillation counter or accelerator mass spectrometry to evaluate radioactivity concentration of each urine（DPM/ml) sample

    Measured: Day-1-Day85

  3. Radioactivity concentration of each feces sample

    Use liquid scintillation counter or accelerator mass spectrometry to evaluate radioactivity concentration of each feces（DPM/ml) sample

    Measured: Day-1-Day85

  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-Day85

  5. Identification of metabolites in plasma, urine and fecal samples

    LC-MS/MS was used to identify the main metabolites in plasma, urine and feces, and finally to provide the main biotransformation pathway of CM082 in human body

    Measured: Day-1-Day85

Secondary outcomes (2)

  1. Pharmacokinetic parameters of unlabeled D-0316 and metabolite D-0865

    To determine the plasma concentrations of D-0316 with validated LC-MS/MS method for obtaining its pharmacokinetics parameters

    Measured: Day-1-Day85

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

    According to CTCAE v4.03, the number and frequency of adverse events after a single dose of test drug were assessed

    Measured: Day-14-Day85

Timeline

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

  1. First posted9 Jul 2020
  2. Study start5 Dec 2020
  3. Primary completionAug 2021 (estimated)
  4. Study completionAug 2021 (estimated)

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04464551
Sponsor's protocol ID
IBIO-105
Status last verified
May 2021
First submitted
3 Jul 2020
Last updated
2 Jun 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]D-0316 suspension in people with Advanced or Metastatic Non-small Cell Lung, run by Betta Pharmaceuticals Co., Ltd. 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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 2 Jun 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?

Results are not available in the source record.

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 plasma sample (time frame: Day 1-Day85). The study lists 5 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 NCT04464551.

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 2 Jun 2021.

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