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RecruitingNCT05893849Updated Jun 8, 2023

Pharmacokinetics of Clinical Probes and Characteristics of Endogenous Biomarker in Chinese Older Adults

An observational study in Aging, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-06-08.

Sponsored by Peking University Third Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
624
Ages
60 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Aging

Keywords

  • Chinese older adults
  • clinical probes
  • endogenous biomarkers
  • drug metabolizing enzymes
  • drug transporters
03

In context

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. 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;
  2. 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);
  3. 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;
  4. 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);
  5. Willingness to comply with the study protocol and sign informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with known history of blood phobia or needle phobia that would preclude safe participation in the study procedures.
  2. 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.)
  3. History of major diseases or newly discovered diseases: prostate cancer, leukemia, liver cancer, breast cancer, colorectal cancer, leukemia and other tumor diseases;
  4. 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
    • 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;
  5. 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);
  6. 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;
  7. Subjects who have participated in clinical trials of any drug or medical device within 3 months prior to screening;
  8. Subjects who have any factors deemed unsuitable for participation in this study.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
624 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    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

    Drug: Clinical probes

Interventions

  • DrugClinical probes

    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.

06

What researchers measure

Primary outcomes

  1. 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

    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

  2. Concentration of clinical probes in urine

    Urine concentration of meropenem and metformin will be quantified and measured by LC-MS/MS or HPLC

    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

  3. 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

    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

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, 100191, China
    • Dongyang Liu · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05893849
Lead sponsor
Peking University Third Hospital
Responsible party
Dongyang Liu (Deputy Director Drug Clinical Trial Center, Peking University Third Hospital) — Principal investigator
First posted
Jun 8, 2023
Start date
Mar 28, 2023
Primary completion
Mar 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Jun 8, 2023

Study contacts

Dongyang Liu
Contact
liudongyang@vip.sina.com
(86)010-82266658
Cheng Cui
Contact
cuicheng1226@163.com
13011825605
Dongyang Liu
principal investigator · Drug Clinical Trial Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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