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Abiraterone AcetateEarly Phase 1NCT04735913

Effects of Metabolic Enzymes and Transporter Gene Polymorphisms on the Pharmacokinetics and Metabolism of Oral Abiraterone Acetate in Healthy Chinese Adults

A Early Phase 1 study testing Abiraterone acetate tablets in people with Abiraterone Acetate and Gene Polymorphism, run by Zhongnan Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

1. To explore the relationship between the changes of plasma concentration of abiraterone acetate after taken orally on fasting or postprandial and gene polymorphism. 2. Study of drug Metabolite profiling after oral administration of abiraterone acetate on fasting and postprandial in Chinese adults. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
What is being tested?
Abiraterone acetate tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteChina
Study dates
5 May 2020to 1 Jul 2022
Phase
Early 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 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age: Healthy male subjects aged 18 to 65 years
  • Weight: weight ≥50.0kg, 19 ≤ BMI ≤ 26 kg/m2, BMI=weight (kg) / height2(m2)
  • Fully aware of the purpose, nature, method and possible adverse reactions of the study, and sign informed consent prior to the commencement of any study procedure on a voluntarily base.
  • Be able to communicate well with the investigator and understand and abide by the terms of the study requirements.

Who cannot join

  • Clinical laboratory examination is abnormal and clinically significant.
  • Vital signs examination is abnormal and clinically significant, or there are other diseases of clinical significance（Including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardio-cerebrovascular disease）or other specific systemic disease.
  • Electrocardiogram is abnormal and clinically significant.
  • HbsAg, Anti - HCV, TPPA, or HIV antibody positive.
  • History of allergy to abiraterone acetate tablets or its ingredients and analogs
  • The number of daily smoking >5 during 3 months before the trial.
Show all 26Show fewer
  • Alcoholics or regular drinkers in the 6 months prior to the trial, that is drinking more than 14 units per week (1 Unit =360mL beer or 45mL 40% liquor or 150mL wine)
  • Positive for drug, has a history of drug abuse in the past five years or has used drugs in the 3 months prior to the trial.
  • Positive for alcohol screening or use of any alcoholic product within 24 hours prior to taking the study drug.
  • Blood donation or massive blood loss within 3 months prior to taking the study drug (>450mL).
  • Take any xanthine rich beverage, food, grapefruit fruit or products that contain grapefruit in 48 hours before the trial.
  • Take in chocolate or any food or drink containing caffeine in 48 hours before the trial.
  • A history of dysphagia or any gastrointestinal disease that affect drug absorption.
  • Have taken the study drug or participated in the drug or medical device within three months before this trial.
  • There are major changes in diet or exercise habits recently.
  • Acute disease occurs during the study screening phase or prior to taking study drugs.
  • There are drug combination of CYP3A4, P-GP, or Bcrp inhibitors or inducers (such as itraconazole, ketoconazole, dronedarone et al.), or any drugs that affect hepatic microsomal enzyme activity during the 28 days before taking the study drug.
  • Accompanied by any coagulation disorders (such as Willebrand's disease or hemophilia) or history of hemorrhagic disease.
  • Accompanied by any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, stomach or duodenal ulcers, etc.
  • Special requirements on diet and fails to comply with the diet provided and the corresponding regulations, especially for the lactose intolerant.
  • History of asthma or seizures.
  • Have a pregnancy plan in 6 months, sperm or egg donation, or reluctance to use one or more non-drug contraceptives during the trial.
  • Taking any prescription drugs, nonprescription drug, over-the-counter, vitamin products, or herbal medicines in 14 days before taking the study drug.
  • Patients with abnormal nucleic acid or antibody detection of COVID-19 and considered ineligible by the investigator.
  • Pulmonary CT were abnormal and considered inappropriate to participate in the study by the investigator.
  • Subjects considered to have poor compliance or have any factors that would make them inappropriate to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430000

Other trials in China

About this study

  1. To explore the relationship between the changes of plasma concentration of abiraterone acetate after taken orally on fasting or postprandial and gene polymorphism.
  2. Study of drug Metabolite profiling after oral administration of abiraterone acetate on fasting and postprandial in Chinese adults.
Read the detailed description

Prostate cancer is the most common malignancy in men currently, second only to lung cancer in China. And in Europe and America, it has already overtaken lung and bowel cancer and become the greatest threat of of men's health. After the diagnosis of high-risk prostate cancer patients, endocrine therapy is still the main treatment. It is effective for most patients who receive androgen deprivation therapy at first. However, after the remission whose median time is 18 to 24 months through endocrine therapy, most patients will turn to castration resistant prostate cancer (CRPC). The treatment of CRPC has always been a difficult point , and now it has become the emphasis of new endocrine drug development for prostate cancer.

Abiraterone acetate tablets in combination with prednisone apply to the treatment of metastatic castration-resistant prostate cancer. It has been approved by the US Food and Drug Administration in 2011 and gotten listing license in China. Abiraterone acetate is an effective irreversible inhibitor CYP17 enzyme and can be converted into abiraterone in vivo. Abiraterone is an androgen biosynthesis inhibitor with a high affinity and selectivity to CYP17. The inhibitory activity of abiraterone for CYP17 was 10-30 times higher than that of ketoconazole. Androgen biosynthesis is inhibited by inhibiting CYP17. The results of many large-scale clinical trials showed that abiraterone acetate could effectively prolong survival time of the patients .

In this study, Blood and plasma samples, urine and faeces samples in 72h from healthy Chinese adult volunteers who have taken abiraterone acetate tablet orally on an empty stomach or after meals were collected for metabolite analysis, the relationship between plasma concentration and gene polymorphism, and identifying the major metabolites in metabolic biological samples to reveal the pharmacokinetic characteristics of abiraterone acetate tablets，demonstrate the pharmacodynamic mechanism，and explore the effect of different genotypes Pharmacokinetic characteristics in healthy Chinese adults.

The result provides theoretical basis for clinical rational drug use.

Being tested
Abiraterone acetate tablets
Keywords
Abiraterone, pharmacokinetic, metabolites, plasma, gene polymorphism

What participants receive

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

  • Abiraterone acetate tabletsDrug

    Subjects will take abiraterone acetate tablets (250 mg, produced by Patheon Ich, trade name: Zytiga®) orally on an empty stomach or after meals and their blood and plasma samples, urine and faeces samples in 72h will be collected for detection.

Study groups in NCT04735913
Study groupRoleWhat they receive
Fasting groupOtherSubjects will take abiraterone acetate tablets (250 mg, produced by Patheon Ich, trade name: Zytiga®) orally on an empty stomach and their blood and plasma samples, urine and faeces samples in 72h will be collected for detection.
Receives: Drug: Abiraterone acetate tablets
Postprandial groupExperimentalSubjects will take abiraterone acetate tablets (250 mg, produced by Patheon Ich, trade name: Zytiga®)orally after meals and their blood and plasma samples, urine and faeces samples in 72h will be collected for detection.
Receives: Drug: Abiraterone acetate tablets

What is being measured

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

  1. Concentrations of abiraterone in plasma

    -1h, 30min, 1h , 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h after administration for blood sampling

    Measured: 2 months

  2. Cmax

    peak concentration

    Measured: 2 months

  3. AUC0-t

    Area under curve. The linear trapezoid method is used to calculate the blood drug concentration from zero to the last measurable concentration area under the curve

    Measured: 2 months

  4. AUC0-∞

    The area under the blood concentration-time curve from zero to infinite blood concentration

    Measured: 2 months

  5. λz

    End phase elimination rate constant, the least square method is used to find the slope of the optimal curve for phase elimination And multiplied by 2.303

    Measured: 2 months

  6. T1/2z

    Elimination or final half-life, 0.693/λz

    Measured: 2 months

  7. AUC_%Extra

    [（AUC0-∞- AUC0-t）/ AUC0-∞]×100%, Percentage of residual area

    Measured: 2 months

  8. Vz/F

    apparent volume of distribution, Vz/F = CLz/F /λz

    Measured: 2 months

  9. CLz/F

    apparent clearance, CLZ /F= administration dose /AUC0-∞

    Measured: 2 months

  10. the main metabolite of abiraterone

    The plasma, urine and feces samples were collected to assay the metabolic profile of abiraterone in vivo by UFLC-Q-Exactive Orbitrap HRMS system

    Measured: 2 months

  11. genotyping related to abiraterone metabolism

    Mutation sites of transporter and metabolic enzyme related to abiraterone metabolism were detected through the gene detection technology service platform

    Measured: 10 months

Timeline

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

  1. First posted3 Feb 2021
  2. Study start5 May 2020
  3. Primary completion20 Aug 2020
  4. Study completion1 Jul 2022 (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
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04735913
Sponsor's protocol ID
20201010
Status last verified
Dec 2021
First submitted
16 Nov 2020
Last updated
3 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Abiraterone acetate tablets in people with Abiraterone Acetate and Gene Polymorphism, run by Zhongnan 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 4 inclusion and 26 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 3 Jan 2022. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Concentrations of abiraterone in plasma (time frame: 2 months). The study lists 11 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 NCT04735913.

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 3 Jan 2022.

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