PharmacokineticsPhase 1NCT06360796
Study of Pharmacokinetics and Metabolism on [(14)C]ADC189
A Phase 1 study testing [(14)C]ADC189 in people with Pharmacokinetics and Metabolism, run by Jiaxing AnDiCon Biotech Co.,Ltd at 1 site in China.
Trial summary
This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Metabolism
- What is being tested?
- [(14)C]ADC189
- 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
- 24 Nov 2023to 20 Feb 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. healthy Chinese male subjects within 18 to 45 years old inclusive;
- 2. body weight over 50 Kg, and within a BMI range of 19.0 to 26.0 kg/m2 inclusive;
- 3. has no sperm donation plan, no family planning and voluntarily adopts strict contraceptive methods during the study period and within six months after the completion of the trial;
- 4. able to comprehend and willing to sign an Informed Consent Form (ICF).
Who cannot join
- 1. history or presence of an abnormal ECG;
- 2. participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in;
- 3. exposure to significant radiation within 12 months prior to Check-in;
- 4. participation in any other investigational study drug trial;
- 5. use of any prescription medications/products within 14 days prior to Check-in;
- 6. use of any drug that affects drug metabolism enzymes or transporters (P-gp and BCRP) in the 30 days prior to taking the study drug, as detailed in Appendix 5;
- 7. receipt of blood products within 1 month prior to Check-in.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affilicated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
About this study
Official title: A Phase I Study to Investigate the Absorption, Metabolism, Excretion, and Safety of [(14)C]ADC189 in Healthy Chinese Male Volunteers
This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants.
Read the detailed description
This study adopted a single-center, open, non-randomized, single-dose design. Six to eight healthy Chinese male subjects were planned to be enrolled, and the final aim is to collect all required samples and data from at least 6 subjects.
After each subject take a single oral dose of 45 mg (about 100 μCi) [14C]ADC189 on Day 1, whole blood, plasma, urine and feces samples were collected at specified time points during the study. The total radioactivity was measured to calculate the ratio of total radioactivity of whole blood to total radioactivity of plasma, pharmacokinetic parameters, recovery rate and excretion pathway data of total radioactivity in whole blood and plasma. Meanwhile, the radioactive metabolite spectrum and structural identification of main metabolites in plasma, urine and feces were performed to obtain the pathway and characteristics of main metabolic elimination of ADC189 in human body, as well as circulating metabolites ≥10% of total radioactivity exposure in plasma.
- Conditions
- Pharmacokinetics, Metabolism
- Being tested
- [(14)C]ADC189
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[(14)C]ADC189Drug
Each subject take a single oral dose of about 45 mg (about 100 μCi) [(14)C]ADC189 on Day 1 of the study, and be observed by 504 hours.
| Study group | Role | What they receive |
|---|---|---|
| ADC189 | Experimental | 45 mg (about 100 μCi) [(14)C]ADC189 Receives: Drug: [(14)C]ADC189 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Area Under the Curve (AUC) of [(14)C]ADC189 and its metabolites
Measured: 504 hours
The Maximum Plasma Concentration [Cmax] of [(14)C]ADC189 and its metabolites
Measured: 504 hours
The whole blood and serum concentrations of total radioactivity of [(14)C]ADC189 (about 100 μCi)
Measured: 504 hours
The urinary and fecal recovery of total radioactivity of [(14)C]ADC189 (about 100 μCi)
Measured: 504 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start24 Nov 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiaxing AnDiCon Biotech Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360796
- Sponsor's protocol ID
- 2023-ADC189-I-010
- Status last verified
- Mar 2024
- First submitted
- 3 Apr 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Investigate the Absorption, Metabolism, Excretion, and Safety of [(14)C]ADC189 in Healthy Chinese Male Volunteers
- ClinicalTrials.gov ID
- NCT06360796
- Acronym / sponsor ID
- 2023-ADC189-I-010
- Conditions
- Pharmacokinetics, Metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jiaxing AnDiCon Biotech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 11 Apr 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.
This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants.
Detailed description
This study adopted a single-center, open, non-randomized, single-dose design. Six to eight healthy Chinese male subjects were planned to be enrolled, and the final aim is to collect all required samples and data from at least 6 subjects.
After each subject take a single oral dose of 45 mg (about 100 μCi) [14C]ADC189 on Day 1, whole blood, plasma, urine and feces samples were collected at specified time points during the study. The total radioactivity was measured to calculate the ratio of total radioactivity of whole blood to total radioactivity of plasma, pharmacokinetic parameters, recovery rate and excretion pathway data of total radioactivity in whole blood and plasma. Meanwhile, the radioactive metabolite spectrum and structural identification of main metabolites in plasma, urine and feces were performed to obtain the pathway and characteristics of main metabolic elimination of ADC189 in human body, as well as circulating metabolites ≥10% of total radioactivity exposure in plasma.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADC189 | Experimental | Drug: [(14)C]ADC18945 mg (about 100 μCi) [(14)C]ADC189 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. healthy Chinese male subjects within 18 to 45 years old inclusive;
- 2. body weight over 50 Kg, and within a BMI range of 19.0 to 26.0 kg/m2 inclusive;
- 3. has no sperm donation plan, no family planning and voluntarily adopts strict contraceptive methods during the study period and within six months after the completion of the trial;
- 4. able to comprehend and willing to sign an Informed Consent Form (ICF).
Key exclusion criteria (7 listed)
- 1. history or presence of an abnormal ECG;
- 2. participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in;
- 3. exposure to significant radiation within 12 months prior to Check-in;
- 4. participation in any other investigational study drug trial;
- 5. use of any prescription medications/products within 14 days prior to Check-in;
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 |
|---|---|---|
| [(14)C]ADC189Each subject take a single oral dose of about 45 mg (about 100 μCi) [(14)C]ADC189 on Day 1 of the study, and be observed by 504 hours. | Drug | ADC189 |
Primary outcome
The Area Under the Curve (AUC) of [(14)C]ADC189 and its metabolites
Time frame: 504 hours
The Maximum Plasma Concentration [Cmax] of [(14)C]ADC189 and its metabolites
Time frame: 504 hours
The whole blood and serum concentrations of total radioactivity of [(14)C]ADC189 (about 100 μCi)
Time frame: 504 hours
The urinary and fecal recovery of total radioactivity of [(14)C]ADC189 (about 100 μCi)
Time frame: 504 hours
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 20 Jan 2025.
- Individual participant dataSharing planned: No
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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 [(14)C]ADC189 in people with Pharmacokinetics and Metabolism, run by Jiaxing AnDiCon Biotech 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 4 inclusion and 7 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 20 Jan 2025. 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 Area Under the Curve (AUC) of [(14)C]ADC189 and its metabolites (time frame: 504 hours). 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?
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 20 Jan 2025.