AgingNCT05893849
Pharmacokinetics of Clinical Probes and Characteristics of Endogenous Biomarker in Chinese Older Adults
An observational study of Aging, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this observational study aims to reveal the pharmacokinetics of clinical probes and characteristics of endogenous biomarkers for drug-metabolizing enzymes and transporters in Chinese older adults and old older adults, to analyze their correlation with frailty, and to explore the exosome characteristics in… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Clinical probes
- How many people
- 624 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2023to Apr 2024
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients aged 60-74 years old (older adults group) and ≥75 years old (old older adults group) with stable underlying disease, takes any one or more of the following clinical probes: omeprazole/rabeprazole/pantoprazole/metoprolol/carvedilol/rivaroxaban/amlodipine/finasteride/simvastatin/meropenem/atorvastatin/rosuvastatin/metformin.
Who may be able to join
- Older adults males and females aged 60-74 years old (older adults group) and ≥75 years old (old older adults group), proportion of either sex must not be less than 1/3 (except for subjects taking finasteride), number of subjects in each frailty category must not be less than 10;
- Male participants must weight ≥45 kg and female participants must weight ≥40 kg. Body mass index (BMI) must be within the range of 18.0-28.0 (inclusive). BMI = weight (kg)/height^2 (m^2);
- Inpatients with stable underlying disease, who takes any one or more of the following clinical probes: omeprazole/rabeprazole/pantoprazole/metoprolol/carvedilol/rivaroxaban/amlodipine/finasteride/simvastatin/meropenem/atorvastatin/rosuvastatin/metformin;
- Creatinine clearance (CRCL) ≥15 mL/min, calculated by CockCroft-Gault equation. CRCL = [(140-age)*(lean body weight, kg)*(0.85 if female)/(72*Scr, mg/dL);
- Willingness to comply with the study protocol and sign informed consent form.
Who cannot join
- Subjects with known history of blood phobia or needle phobia that would preclude safe participation in the study procedures.
- History of disease or an emerging disease within the past 1 month that could affect the study: Diseases affecting the abundance and activity of liver drug enzymes or transporters: cancer, diabetes (except metformin group), acute kidney injury, liver disease (cirrhosis, liver cancer, severe liver injury, severe fatty liver, liver abscess, internal bile duct stones, etc.)
- History of major diseases or newly discovered diseases: prostate cancer, leukemia, liver cancer, breast cancer, colorectal cancer, leukemia and other tumor diseases;
- Drugs that may affect the study were consumed within 1 week prior to screening:
- Patients taking omeprazole/rabeprazole/pantoprazole: Potent CYP2C19 inhibitors: ASP8477, fluconazole, fluoxetine, fluvoxamine, ticlopidine; Potent CYP2C19 inducers: apalutamide, rifampicin, ritonavir;
- Patients taking metoprolol/carvedilol: Potent CYP2D6 inhibitors: ASP8477, bupropion, fluoxetine, paroxetine, quinidine
Show all 13Show fewer
- Patients taking rivaroxaban/amlodipine/finasteride/simvastatin/atorvastatin: Potent CYP3A inhibitor: boceprevir, ceritinib, conivaptan hydrochloride, verapamil, diltiazem, aprepitant, quinidine, dronedarone, tacrolimus, protease inhibitors (ritonavir, indinavir, nelfinavir, saquinavir, lopinavir), macrolides antibiotics (erythromycin, clarithromycin, telithromycin), chloramphenicol, antifungal drugs (ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole, miconazole) nefazoldone, cobistat, cimetidine, ciprofloxacin, fluvoxamine, imatinib, St. John's wort, ranolazine; Potent CYP3A inducers: apalutamide, avomibe, rifampicin, carbamazepine, enzalutamide, ivosidenib, mitotane, phenytoin, rifapentine
- Patients taking meropenem: Potent OAT inhibitors: aminohippuric acid, probenecid, teriflunomide
- Patients taking simvastatin/atorvastatin/rosuvastatin: Potent OATP1B1 inhibitor: protease inhibitor (atazanavir, ritonavir, lopinavir, simeprevir), cyclosporin, macrolides antibiotics (erythromycin, clarithromycin), rifampicin;
- Subjects who have smoking addict or alcohol abuse and do not agree to abstain from smoking or drinking during the trial period (smoking addict: average of ≥5 cigarettes daily; alcohol abuse: average of ≥100mL hard liquor);
- Tested positive on virological test (human immunodeficiency virus antibody (HIV-Ab)), syphilis serological test, hepatitis B virus surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab) within 6 months prior to screening;
- Subjects who have participated in clinical trials of any drug or medical device within 3 months prior to screening;
- Subjects who have any factors deemed unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Dongyang Liu
About this study
Official title: A Single Center, Open Label Study of Pharmacokinetics of Clinical Probes and Characteristics of Endogenous Biomarker for Drug-metabolizing Enzymes and Transporters in Chinese Older Adults
The goal of this observational study aims to reveal the pharmacokinetics of clinical probes and characteristics of endogenous biomarkers for drug-metabolizing enzymes and transporters in Chinese older adults and old older adults, to analyze their correlation with frailty, and to explore the exosome characteristics in this population.
Read the detailed description
This study is a non-intervention observational study in Chinese older adults and will not interfere with the routine medical treatment. 6-10 mL whole blood and 20 mL urine samples (only applicable for patients taking meropenem and metformin) will be collected from eligible subjects according to medical routine blood collection time. Concentration of clinical probes and respective metabolites (when required), endogenous biomarkers, genotype information of drug-metabolizing enzymes and transporters, and the exosome characteristics will be quantified or measured.
- Conditions
- Aging
- Being tested
- Clinical probes
- Keywords
- Chinese older adults, clinical probes, endogenous biomarkers, drug metabolizing enzymes, drug transporters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical probesDrug
Inpatients taking one or more clinical probes of CYP2C19 (omeprazole, rabeprazole, pantoprazole), CYP2D6 (metoprolol, carvedilol), CYP3A4 (rivaroxaban, finasteride, amlodipine, simvastatin), OAT (meropenem), OATP1B1 (atorvastatin, rosuvastatin) and OCT (metformin) will be included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Older adults | Aged 60-74 years old, takes omeprazole or rabeprazole or pantoprazole or metoprolol or carvedilol or amlodipine or finasteride or simvastatin or rivaroxaban or meropenem or atorvastatin or rosuvastatin or metformin Receives: Drug: Clinical probes | |
| Old older adults | Aged >75 years old, takes omeprazole or rabeprazole or pantoprazole or metoprolol or carvedilol or amlodipine or finasteride or simvastatin or rivaroxaban or meropenem or atorvastatin or rosuvastatin or metformin Receives: Drug: Clinical probes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of clinical probes in plasma
Plasma concentration of clinical probes and the respective metabolites (when required) will be quantified and measured by LC-MS/MS or HPLC
Measured: Sampling will be performed according to routine medical follow-up, which should be no less than 3 samples over the period of one year
Concentration of clinical probes in urine
Urine concentration of meropenem and metformin will be quantified and measured by LC-MS/MS or HPLC
Measured: Urine samples will be collected at any administration intervals, which should be no less than 1 sample over the period of one year
Level of endogenous biomarker
The level of endogenous biomarker (Dihydroxyeicosatrienoic acids, DHETs, 4β-hydroxycholesterol/cholesterol ratio, 4β-OHC/CHO, pyridoxic acids, PDA, Coproporphyrin, CP) will be quantified and measured by LC-MS/MS or HPLC or ELISA
Measured: sampling will be performed according to routine medical follow-up, which should be no less than 3 samples over the period of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start28 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongyang Liu, Peking University Third Hospital
- Investigators
- Dongyang Liu, Principal investigator, Drug Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893849
- Sponsor's protocol ID
- M2022778
- Status last verified
- Jun 2023
- First submitted
- 16 Mar 2023
- Last updated
- 8 Jun 2023
- 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 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label Study of Pharmacokinetics of Clinical Probes and Characteristics of Endogenous Biomarker for Drug-metabolizing Enzymes and Transporters in Chinese Older Adults
- ClinicalTrials.gov ID
- NCT05893849
- Acronym / sponsor ID
- M2022778
- Conditions
- Aging
- Keywords
- Chinese older adults, clinical probes, endogenous biomarkers, drug metabolizing enzymes, drug transporters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 8 Jun 2023 (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.
The goal of this observational study aims to reveal the pharmacokinetics of clinical probes and characteristics of endogenous biomarkers for drug-metabolizing enzymes and transporters in Chinese older adults and old older adults, to analyze their correlation with frailty, and to explore the exosome characteristics in this population.
Detailed description
This study is a non-intervention observational study in Chinese older adults and will not interfere with the routine medical treatment. 6-10 mL whole blood and 20 mL urine samples (only applicable for patients taking meropenem and metformin) will be collected from eligible subjects according to medical routine blood collection time. Concentration of clinical probes and respective metabolites (when required), endogenous biomarkers, genotype information of drug-metabolizing enzymes and transporters, and the exosome characteristics will be quantified or measured.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older adults | – | Drug: Clinical probesAged 60-74 years old, takes omeprazole or rabeprazole or pantoprazole or metoprolol or carvedilol or amlodipine or finasteride or simvastatin or rivaroxaban or meropenem or atorvastatin or rosuvastatin or metformin |
| Old older adults | – | Drug: Clinical probesAged >75 years old, takes omeprazole or rabeprazole or pantoprazole or metoprolol or carvedilol or amlodipine or finasteride or simvastatin or rivaroxaban or meropenem or atorvastatin or rosuvastatin or metformin |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients aged 60-74 years old (older adults group) and ≥75 years old (old older adults group) with stable underlying disease, takes any one or more of the following clinical probes: omeprazole/rabeprazole/pantoprazole/metoprolol/carvedilol/rivaroxaban/amlodipine/finasteride/simvastatin/meropenem/atorvastatin/rosuvastatin/metformin.
Key inclusion criteria (5 listed)
- Older adults males and females aged 60-74 years old (older adults group) and ≥75 years old (old older adults group), proportion of either sex must not be less than 1/3 (except for subjects taking finasteride), number of subjects in each frailty category must not be less than 10;
- Male participants must weight ≥45 kg and female participants must weight ≥40 kg. Body mass index (BMI) must be within the range of 18.0-28.0 (inclusive). BMI = weight (kg)/height^2 (m^2);
- Inpatients with stable underlying disease, who takes any one or more of the following clinical probes: omeprazole/rabeprazole/pantoprazole/metoprolol/carvedilol/rivaroxaban/amlodipine/finasteride/simvastatin/meropenem/atorvastatin/rosuvastatin/metformin;
- Creatinine clearance (CRCL) ≥15 mL/min, calculated by CockCroft-Gault equation. CRCL = [(140-age)*(lean body weight, kg)*(0.85 if female)/(72*Scr, mg/dL);
- Willingness to comply with the study protocol and sign informed consent form.
Key exclusion criteria (13 listed)
- Subjects with known history of blood phobia or needle phobia that would preclude safe participation in the study procedures.
- History of disease or an emerging disease within the past 1 month that could affect the study: Diseases affecting the abundance and activity of liver drug enzymes or transporters: cancer, diabetes (except metformin group), acute kidney injury, liver disease (cirrhosis, liver cancer, severe liver injury, severe fatty liver, liver abscess, internal bile duct stones, etc.)
- History of major diseases or newly discovered diseases: prostate cancer, leukemia, liver cancer, breast cancer, colorectal cancer, leukemia and other tumor diseases;
- Drugs that may affect the study were consumed within 1 week prior to screening:
- Subjects who have smoking addict or alcohol abuse and do not agree to abstain from smoking or drinking during the trial period (smoking addict: average of ≥5 cigarettes daily; alcohol abuse: average of ≥100mL hard liquor);
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 |
|---|---|---|
| Clinical probesInpatients taking one or more clinical probes of CYP2C19 (omeprazole, rabeprazole, pantoprazole), CYP2D6 (metoprolol, carvedilol), CYP3A4 (rivaroxaban, finasteride, amlodipine, simvastatin), OAT (meropenem), OATP1B1 (atorvastatin, rosuvastatin) and OCT (metformin) will be included in the study. | Drug | Old older adults, Older adults |
Primary outcome
Concentration of clinical probes in plasma
Time frame: Sampling will be performed according to routine medical follow-up, which should be no less than 3 samples over the period of one year
Plasma concentration of clinical probes and the respective metabolites (when required) will be quantified and measured by LC-MS/MS or HPLC
Concentration of clinical probes in urine
Time frame: Urine samples will be collected at any administration intervals, which should be no less than 1 sample over the period of one year
Urine concentration of meropenem and metformin will be quantified and measured by LC-MS/MS or HPLC
Level of endogenous biomarker
Time frame: sampling will be performed according to routine medical follow-up, which should be no less than 3 samples over the period of one year
The level of endogenous biomarker (Dihydroxyeicosatrienoic acids, DHETs, 4β-hydroxycholesterol/cholesterol ratio, 4β-OHC/CHO, pyridoxic acids, PDA, Coproporphyrin, CP) will be quantified and measured by LC-MS/MS or HPLC or ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- 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.
Dongyang Liu principal investigator
Drug Clinical Trial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by Peking University Third Hospital 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 13 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 8 Jun 2023. 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.
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?
Contact Dongyang Liu ((86)010-82266658, liudongyang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of clinical probes in plasma (time frame: Sampling will be performed according to routine medical follow-up, which should be no less than 3 samples over the period of one year). The study lists 3 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 8 Jun 2023.