Mass Balance StudyPhase 1NCT06233916

Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects

A Phase 1 study testing [14C] D-1553 in people with Mass Balance Study, run by InventisBio Co., Ltd at 1 site in China.

Completed

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

Trial summary

To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral dose of [14C] D-1553 in healthy subjects, and obtain radioactivity recovery and primary excretion pathways in humans; To obtain radioactive metabolite profiles of human plasma, urine and feces , identify major metabolites of… Read more about this study

Who is it for?: Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Mass Balance Study
What is being tested?: [14C] D-1553
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteChina
Study dates: 8 Dec 2023to 10 Jan 2024
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 19 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Subjects who volunteer to participate in this clinical trial, understand the study procedures and sign the Informed Consent Form (ICF) in writing.
Healthy Chinese adult male subjects aged 19-55 years (inclusive) at the time of signing the ICF.
Body weight ≥ 50.0 kg, 19 kg/m2 ≤ body mass index (BMI) ≤ 26.0 kg/m2, and BMI = body weight (kg)/body height2 (m2) at screening.
Subjects with normal test results or with abnormal but not clinically significant results as judged by the clinician for vital signs, physical examination, 12-lead ECG, chest radiograph (PA view), abdominal color Doppler ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), ophthalmological examination, and laboratory tests (including hematology, blood chemistry, coagulation function, urinalysis, thyroid function, screening for infectious diseases, stool routine test + occult blood) during screening.
Subjects who agree to abstain, are surgically sterilized, or agree to use an effective contraceptive method from the time of signing the ICF and for the duration of study participation to 180 days after administration of the study drug.

Who cannot join

Subjects with any medical history of disorders of the central nervous system, cardiovascular system, blood and lymphatic system, immune system, urinary system, digestive system, respiratory system, and metabolic and skeletal system, etc., other acute or chronic diseases or mental diseases, which are abnormal and clinically significant at the discretion of the investigator.
Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody, treponema pallidum antibody (TPA), or HIV antigen/antibody combination test (preliminary screening).
Subjects who have smoked more than 5 cigarettes or 1 pipe per day (or equivalent of nicotine products) on average within 3 months prior to screening, or who are unable to stop using any tobacco products during the trial.
Subjects with hemorrhoids with hematochezia or perianal disease with regular/ongoing hematochezia, or with severe nausea, vomiting, constipation or diarrhea within one week prior to screening; or with positive test results for fecal occult blood.
Subjects with a history of blood or needle phobia.
Subjects who have undergone a major surgery that affects the absorption or metabolism of the study drug within 6 months prior to the first dose.

Show all 11Show fewer

Subjects who have participated in clinical trials of other study drugs within 3 months before the first dose; if the half-life of that other investigational drug is long, the time period is limited to 5 half-lives of the drug.
Subjects unwilling or unable to follow the life restrictions described in the study protocol (such as dietary restrictions, activity and contraceptive requirements, etc.).
Subjects who have lost blood or donated blood, or received blood transfusions or used blood products within 1 month before administration.
Subjects who are exposed to radioactive work conditions for a long time, or have significant radiation exposure (≥ 2 chest/abdominal CTs, or ≥ 3 other types of X-ray examinations) within 1 year before the first dose, or have participated in a radiopharmaceutical labeled trial.
Subjects who are unsuitable for the study participation for other reasons at the discretion of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

beijing Gobroad Boren Hospital
Beijing

Other trials in China

About this study

To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral dose of [14C] D-1553 in healthy subjects, and obtain radioactivity recovery and primary excretion pathways in humans;
To obtain radioactive metabolite profiles of human plasma, urine and feces , identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways;
To quantitatively analyze the TRA in whole blood and plasma and obtain PK parameters of plasma TRA and investigate whole blood/plasma ratio for TRA.

Read the detailed description

Primary Objectives:

To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral dose of [14C] D-1553 in healthy subjects, and obtain radioactivity recovery and primary excretion pathways in humans;
To obtain radioactive metabolite profiles of human plasma, urine and feces after a single oral dose of [14C] D-1553 in healthy subjects, identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways;
To quantitatively analyze the TRA in whole blood and plasma after a single oral dose of [14C] D-1553 in subjects, and obtain PK parameters of plasma TRA and investigate whole blood/plasma ratio for TRA.

Secondary Objectives:

To observe the safety of a single oral dose of [14C] D-1553 in healthy subjects;
To quantitatively analyze the concentration of D-1553 and its metabolites (if applicable) in plasma using the validated LC-MS (liquid chromatography-mass spectrometry)/MS method and obtain the pharmacokinetic (PK) parameters of D-1553 and its metabolites (if applicable) in plasma.

Conditions: Mass Balance Study
Being tested: [14C] D-1553

What participants receive

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

[14C] D-1553Drug
[14C] D-1553 (approximately 400 mg/80 μCi)

Study groups in NCT06233916
Study group	Role	What they receive
[14C] D-1553 group	Other	Single arm study Receives: Drug: [14C] D-1553

What is being measured

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

The radioactivity will be determined by a liquid scintillation counter. Analyze the total recovery (that is the ratio of the radioactivity in excrement samples to the radioactivity of the drug that administered ) in excrement
Recovery and cumulative recovery of total radioactive substance in excrement (urine and feces)
Measured: 2 weeks
Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose
Exposure in plasma; percentage of unchanged drug and its metabolites in urine and feces to the administered dose; identification of major metabolites in plasma, urine and feces
Measured: 2 weeks
whole blood/plasma ratio for TRA (total radioactivity) concentration at different time points
whole blood/plasma ratio for TRA concentration at different time points
Measured: 2 weeks
Tmax (time to maximum observed concentration) parameters of TRA;
Tmax parameters of TRA in plasma
Measured: baseline to 2 weeks
t1/2 (terminal elimination half-life) parameters of TRA;
t1/2 parameters of TRA in plasma
Measured: baseline to 2 weeks
Cmax (maximum concentration) parameters of TRA;
Cmax parameters of TRA in plasma
Measured: baseline to 2 weeks
MRT (mean residence time) parameters of TRA;
MRT parameters of TRA in plasma
Measured: baseline to 2 weeks
AUC (area under curve) parameters of TRA;
AUC parameters of TRA in plasma
Measured: baseline to 2 weeks

Secondary outcomes (9)

Incidence and severity of AEs based on NCI CTCAE V5.0
Incidence and severity of adverse events (AEs) graded based on NCI CTCAE V5.0
Measured: baseline to 3 weeks
Incidence and severity of SAEs based on NCI CTCAE V5.0
Incidence and severity of serious adverse events (SAEs) graded based on NCI CTCAE V5.0
Measured: baseline to 3 weeks
Tmax parameters of D-1553 and its metabolites
Tmax parameters of D-1553 and its metabolites (if applicable) in plasma
Measured: baseline to 2 weeks
Cmax parameters of D-1553 and its metabolites
Cmax parameters of D-1553 and its metabolites (if applicable) in plasma
Measured: baseline to 2 weeks
AUC0-t parameters of D-1553 and its metabolites
AUC0-t parameters of D-1553 and its metabolites (if applicable) in plasma
Measured: baseline to 2 weeks
T1/2 parameters of D-1553 and its metabolites
T1/2 parameters of D-1553 and its metabolites (if applicable) in plasma
Measured: baseline to 2 weeks
MRT parameters of D-1553 and its metabolites
MRT parameters of D-1553 and its metabolites (if applicable) in plasma
Measured: baseline to 2 weeks
CL/F (apparent clearance) parameters of D-1553 and its metabolites
CL/F parameters of D-1553 and its metabolites (if applicable) in plasma
Measured: baseline to 2 weeks
Vz/F (apparent volume of distribution) parameters of D-1553 and its metabolites
Vz/F parameters of D-1553 and its metabolites (if applicable) in plasma
Measured: baseline to 2 weeks

Timeline

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

8 Dec 202310 Jan 2024

First posted31 Jan 2024
Study start8 Dec 2023
Primary completion3 Jan 2024
Study completion10 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mass Balance StudyStudies of the same condition, open and under way.
More trials run by InventisBio Co., LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06233916
Sponsor's protocol ID: D1553-108
Status last verified: Jan 2024
First submitted: 27 Nov 2023
Last updated: 1 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
RecruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
Not yet recruitingPhase 1
Mass Balance Study of [14C]DA-302168S in Healthy Chinese Adult Male Participants
Healthy Adult Subjects

All Mass Balance Study trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT06233916
Acronym / sponsor ID: D1553-108
Conditions: Mass Balance Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: InventisBio Co., LtdIndustry (pharma, biotech, devices)
Study start: 8 Dec 2023 (actual)
Primary completion: 3 Jan 2024 (actual)
Study completion: 10 Jan 2024 (actual)
First posted: 31 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral dose of [14C] D-1553 in healthy subjects, and obtain radioactivity recovery and primary excretion pathways in humans;
To obtain radioactive metabolite profiles of human plasma, urine and feces , identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways;
To quantitatively analyze the TRA in whole blood and plasma and obtain PK parameters of plasma TRA and investigate whole blood/plasma ratio for TRA.

Detailed description

Primary Objectives:

To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral dose of [14C] D-1553 in healthy subjects, and obtain radioactivity recovery and primary excretion pathways in humans;
To obtain radioactive metabolite profiles of human plasma, urine and feces after a single oral dose of [14C] D-1553 in healthy subjects, identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways;
To quantitatively analyze the TRA in whole blood and plasma after a single oral dose of [14C] D-1553 in subjects, and obtain PK parameters of plasma TRA and investigate whole blood/plasma ratio for TRA.

Secondary Objectives:

To observe the safety of a single oral dose of [14C] D-1553 in healthy subjects;
To quantitatively analyze the concentration of D-1553 and its metabolites (if applicable) in plasma using the validated LC-MS (liquid chromatography-mass spectrometry)/MS method and obtain the pharmacokinetic (PK) parameters of D-1553 and its metabolites (if applicable) in plasma.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
[14C] D-1553 group	Other	Drug: [14C] D-1553Single arm study

Who may qualify

Ages: 19 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Subjects who volunteer to participate in this clinical trial, understand the study procedures and sign the Informed Consent Form (ICF) in writing.
Healthy Chinese adult male subjects aged 19-55 years (inclusive) at the time of signing the ICF.
Body weight ≥ 50.0 kg, 19 kg/m2 ≤ body mass index (BMI) ≤ 26.0 kg/m2, and BMI = body weight (kg)/body height2 (m2) at screening.
Subjects with normal test results or with abnormal but not clinically significant results as judged by the clinician for vital signs, physical examination, 12-lead ECG, chest radiograph (PA view), abdominal color Doppler ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), ophthalmological examination, and laboratory tests (including hematology, blood chemistry, coagulation function, urinalysis, thyroid function, screening for infectious diseases, stool routine test + occult blood) during screening.
Subjects who agree to abstain, are surgically sterilized, or agree to use an effective contraceptive method from the time of signing the ICF and for the duration of study participation to 180 days after administration of the study drug.

Key exclusion criteria (11 listed)

Subjects with any medical history of disorders of the central nervous system, cardiovascular system, blood and lymphatic system, immune system, urinary system, digestive system, respiratory system, and metabolic and skeletal system, etc., other acute or chronic diseases or mental diseases, which are abnormal and clinically significant at the discretion of the investigator.
Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody, treponema pallidum antibody (TPA), or HIV antigen/antibody combination test (preliminary screening).
Subjects who have smoked more than 5 cigarettes or 1 pipe per day (or equivalent of nicotine products) on average within 3 months prior to screening, or who are unable to stop using any tobacco products during the trial.
Subjects with hemorrhoids with hematochezia or perianal disease with regular/ongoing hematochezia, or with severe nausea, vomiting, constipation or diarrhea within one week prior to screening; or with positive test results for fecal occult blood.
Subjects with a history of blood or needle phobia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
[14C] D-1553[14C] D-1553 (approximately 400 mg/80 μCi)	Drug	[14C] D-1553 group

Primary outcome

The radioactivity will be determined by a liquid scintillation counter. Analyze the total recovery (that is the ratio of the radioactivity in excrement samples to the radioactivity of the drug that administered ) in excrement
Time frame: 2 weeks
Recovery and cumulative recovery of total radioactive substance in excrement (urine and feces)
Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose
Time frame: 2 weeks
Exposure in plasma; percentage of unchanged drug and its metabolites in urine and feces to the administered dose; identification of major metabolites in plasma, urine and feces
whole blood/plasma ratio for TRA (total radioactivity) concentration at different time points
Time frame: 2 weeks
whole blood/plasma ratio for TRA concentration at different time points
Tmax (time to maximum observed concentration) parameters of TRA;
Time frame: baseline to 2 weeks
Tmax parameters of TRA in plasma
t1/2 (terminal elimination half-life) parameters of TRA;
Time frame: baseline to 2 weeks
t1/2 parameters of TRA in plasma
Cmax (maximum concentration) parameters of TRA;
Time frame: baseline to 2 weeks
Cmax parameters of TRA in plasma
MRT (mean residence time) parameters of TRA;
Time frame: baseline to 2 weeks
MRT parameters of TRA in plasma
AUC (area under curve) parameters of TRA;
Time frame: baseline to 2 weeks
AUC parameters of TRA in plasma

9 secondary outcomes

Incidence and severity of AEs based on NCI CTCAE V5.0
Time frame: baseline to 3 weeks
Incidence and severity of SAEs based on NCI CTCAE V5.0
Time frame: baseline to 3 weeks
Tmax parameters of D-1553 and its metabolites
Time frame: baseline to 2 weeks
Cmax parameters of D-1553 and its metabolites
Time frame: baseline to 2 weeks
AUC0-t parameters of D-1553 and its metabolites
Time frame: baseline to 2 weeks
T1/2 parameters of D-1553 and its metabolites
Time frame: baseline to 2 weeks
MRT parameters of D-1553 and its metabolites
Time frame: baseline to 2 weeks
CL/F (apparent clearance) parameters of D-1553 and its metabolites
Time frame: baseline to 2 weeks
Vz/F (apparent volume of distribution) parameters of D-1553 and its metabolites
Time frame: baseline to 2 weeks

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
Individual participant dataSharing planned: No

Related trials for Mass Balance Study

RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
RecruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
Not yet recruitingPhase 1
Mass Balance Study of [14C]DA-302168S in Healthy Chinese Adult Male Participants
Healthy Adult Subjects

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C] D-1553 in people with Mass Balance Study, run by InventisBio 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 11 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 1 Feb 2024. 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?

The radioactivity will be determined by a liquid scintillation counter. Analyze the total recovery (that is the ratio of the radioactivity in excrement samples to the radioactivity of the drug that administered ) in excrement (time frame: 2 weeks). The study lists 8 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 NCT06233916.

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 1 Feb 2024.