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Healthy Male VolunteersPhase 1NCT04444011

Pharmacokinetic Interactions of Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth

A Phase 1 study testing Anaprazole Sodium, Amoxicillin and Clarithromycin in people with Healthy Male Volunteers, run by Sihuan Pharmaceutical Holdings Group Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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

A single-center, randomized, open-label, crossover study to evaluate the pharmacokinetic drug-drug interaction and safety of the quadruple therapy with Anaprazole 20mg/Amoxicilin 1000mg/Clarithromycin 500mg/Bismuth Potassium Citrate 0.6g in healthy Chinese male subjects. Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Male Volunteers
What is being tested?
Anaprazole Sodium, Amoxicillin and Clarithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
1 Jul 2020to 15 Oct 2020
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 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1.The subject is capable of understanding and complying with protocol requirements, and signed and dated a written informed consent form voluntarily
  • 2.The subject is a Chinese adult male, aged 18 to 35 years, inclusive.
  • 3.The subject is a H. pylori-negative via UBT.
  • 4.The subject weighed at least 50.0 kg and had a body mass index (BMI) between 19.0 kg/m^2 and 26.0 kg/m^2, inclusive.
  • 5.Has clinical laboratory evaluations, vital signs and ECG testing within the reference range, and medical history and physicial examination results are normal. Participants with evaluations outside the reference range that are deemed not clinically significant by the investigator may be included at investigator discretion
  • 6.The subject with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 3 months after last dose.
  • 7.The subjects have a good lifestyle and can keep good communication with the investigators and comply with the requirements of clinical trial

Who cannot join

  • 1.Has clinical significant drug allergy or allergic disease history(Such as asthma, urticaria, eczema dermatitis, etc), or has hypersensitivity or allergy to investigatory drugs or related supplements；
  • 2.Has clinical significant ECG abnormal history or family history of long QT syndrome(Grandparents, parents and siblings)
  • 3.Any disease or medical history that may significantly affect the absorption, distribution, metabolism, and excretion of drugs, or any condition that may pose a hazard to the subject. Such as:
  • Inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal / rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities;
  • Has suffered from gastrointestinal diseases or complications that may affect the absorption of drugs (ie: malabsorption, gastroesophageal reflux, peptic ulcer, erosive esophagitis, frequent heartburn) within 6 months before screening or had history of gastrointestinal surgery (for example: gastrectomy, gastrointestinal anastomosis, intestinal resection, gastric bypass, gastric segmentation or gastric banding, cholecystectomy, except for appendicitis surgery and proctectomy);
  • Evidence of liver disease or clinically impaired liver function at the time of screening (eg AST, ALT or total bilirubin> 1.5 times ULN);
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  • A history or evidence of nephropathy or renal insufficiency at the time of screening, showing clinically significant abnormality of creatinine or abnormal urine composition (such as proteinuria, creatinine> 176.8 umol / L, etc.)
  • Has difficulty swallowing oral preparations.
  • 4.Thyroid stimulating hormone (TSH)> ULN; or serum free triiodothyronine (FT3)> ULN; or serum free thyroxine (FT4)> ULN at the time of screening;
  • 5. Frequent smokers and alcoholics within 3 months before screening (smoke more than 5 cigarettes / day, drink more than 21 units of alcohol per week, 1 unit = 360 mL beer or 45 mL liquor or 150 mL wine), or can't stop using any tobacco products, and alcohol intake during the study period ; or those who have a positive alcohol breath test before enrollment;
  • 6. Has received any investigational compound (including post-marketing investigational drugs) or participated in clinical trials of any drugs /devices within 3 months before screening;
  • 7. A history of drug abuse within 12 months before screening or a positive urine test result at screening;
  • 8. Has used any prescription drugs, non-prescription drugs (including chemical drugs, vitamin drugs, Chinese herbal medicines, etc.) within 4 weeks before administration of investigational drugs;
  • 9. Has taken foods that affect CYP3A4 (such as grapefruit or beverages containing grapefruit) within 2 weeks before administration of investigational drugs;
  • 10. Human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C antibody, and Treponema pallidum specific antibody test results were positive at screening;
  • 11. Has difficulty in venous blood collection or halo acupuncture;
  • 12.Blood donation / blood loss ≥200 mL within 1 month, or ≥400 mL within 3 months before screening; or has blood donation plan during the period of medication of investigational drugs and within 3 months after drug withdrawal;
  • 13. Has special dietary requirements and cannot follow the unified dietary arrangements;
  • 14. Any conditions in which considered by investigator not be appropriate to participate in this trial.

About this study

Official title: A Single-center, Randomized, Open-label, Crossover Study to Evaluate the Pharmacokinetic Drug-drug Interaction of the Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth in Healthy Chinese Male Subjects

A single-center, randomized, open-label, crossover study to evaluate the pharmacokinetic drug-drug interaction and safety of the quadruple therapy with Anaprazole 20mg/Amoxicilin 1000mg/Clarithromycin 500mg/Bismuth Potassium Citrate 0.6g in healthy Chinese male subjects.

Read the detailed description

The study composed of 2 cohorts, using a 4*4 or 2*2 crossover design in cohort 1 and 2, respectively. 4 rotating treatment sequences in cohort 1, each treatment sequence comprised 4 treatment periods, separated by a washout period of 9 days; 2 rotating treatment sequences in cohort 2, each treatment sequence comprised 2 treatment periods, separated by a washout period of 9 days

Being tested
Anaprazole Sodium, Amoxicillin, Clarithromycin, Bismuth

What participants receive

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

  • Anaprazole SodiumDrug

    Anaprazole Sodium isthePPI inhibitor

  • AmoxicillinDrug

    antibiotic

  • ClarithromycinDrug

    antibiotic

  • BismuthDrug

    Bismuth is to protect the gastric mucosa

Study groups in NCT04444011
Study groupRoleWhat they receive
Anaprazole Sodium enteric-coated tabletExperimentalAdministered orally twice daily (e.g., 8am,8pm) for 5 consecutive days in 1 of 4 treatment periods of cohort 1 ( only once on the morning of D5 of treatment periods), one tablet each time.
Receives: Drug: Anaprazole Sodium
Amoxicillin capsulesExperimental"Administered orally twice daily (e.g., 8am,8pm) for 5 consecutive days in 1 of 4 treatment periods of cohort 1 ( only once on the morning of D5 of treatment periods), 2 capsules each time.
Receives: Drug: Amoxicillin
Clarithromycin tabletExperimental"Administered orally twice daily (e.g., 8am,8pm) for 5 consecutive days in 1 of 4 treatment periods of cohort 1 ( only once on the morning of D5 of treatment periods), 2 tablets each time.
Receives: Drug: Clarithromycin
Anaprazole + Amoxicillin +ClarithromycinExperimental"Cohort 1: Administered orally twice daily (e.g., 8am,8pm) for 5 consecutive days in 1 of 4 treatment periods ( only once on the morning of D5 of treatment periods). Cohort 2: Administered orally on an empty stomach once on the morning of D1 of treatment periods
Receives: Drug: Anaprazole Sodium; Drug: Amoxicillin; Drug: Clarithromycin
Anaprazole + Amoxicillin +Clarithromycin+BismuthExperimentalAdministered orally on an empty stomach once on the morning of D1 of treatment periods in cohort 2
Receives: Drug: Anaprazole Sodium; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Bismuth

What is being measured

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

  1. Cohort 1: Css,max of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites (KBP-1123 and KBP-1144), Unchanged amoxicillin, Unchanged clarithromycin and its metabolite (14-hydroxyclarithromycin)

    Css,max is the peak plasma concentration at steady state

    Measured: Hour 0.5 pre-dose and 0.5，1，1.5，2，2.5，3，3.5，4，4.5，5，6，7，8，10，12，24 hours post-dose of Day 5，Day 19，Day 33，Day 47

  2. Cohort 1: AUC of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites (KBP-1123 and KBP-1144), Unchanged amoxicillin, Unchanged clarithromycin and its metabolite (14-hydroxyclarithromycin)

    AUC is area under the plasma concentration-time curve

    Measured: Hour 0.5 pre-dose and 0.5，1，1.5，2，2.5，3，3.5，4，4.5，5，6，7，8，10，12，24 hours post-dose of Day 5，Day 19，Day 33，Day 47

  3. Cohort 2: Cmax of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites (KBP-1123 and KBP-1144), Unchanged amoxicillin, Unchanged clarithromycin and its metabolite (14-hydroxyclarithromycin)

    Cmax is the peak plasma concentration

    Measured: Hour 0.5 pre-dose and 0.5，1，1.5，2，2.5，3，3.5，4，4.5，5，6，7，8，10，12，24 hours post-dose of Day 1，Day 11

  4. Cohort 2: AUC of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites (KBP-1123 and KBP-1144), Unchanged amoxicillin, Unchanged clarithromycin and its metabolite (14-hydroxyclarithromycin)

    AUC is area under the plasma concentration-time curve

    Measured: Hour 0.5 pre-dose and 0.5，1，1.5，2，2.5，3，3.5，4，4.5，5，6，7，8，10，12，24 hours post-dose of Day 1，Day 11

Secondary outcomes (1)

  1. Number of subjects with adverse events and serious adverse events as assessed by CTCAE v5.0

    All adverse events will be monitored in each subject

    Measured: From signing informed consent to study completion. 56 days minimum, 68 days maximum(Cohort 1); 30 days minimum, 32 days maximum(Cohort 2)

Timeline

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

  1. First posted23 Jun 2020
  2. Study start1 Jul 2020 (estimated)
  3. Primary completion30 Sep 2020 (estimated)
  4. Study completion15 Oct 2020 (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
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04444011
Sponsor's protocol ID
3571-DDI-1006
Status last verified
Mar 2020
First submitted
15 May 2020
Last updated
23 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anaprazole Sodium, Amoxicillin and Clarithromycin in people with Healthy Male Volunteers, run by Sihuan Pharmaceutical Holdings Group Ltd..

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 7 inclusion and 19 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 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Cohort 1: Css,max of anaprazole (parent drug, KBP-3571) and its enantiomer（KBP-3570）and its major metabolites (KBP-1123 and KBP-1144), Unchanged amoxicillin, Unchanged clarithromycin and its metabolite (14-hydroxyclarithromycin) (time frame: Hour 0.5 pre-dose and 0.5，1，1.5，2，2.5，3，3.5，4，4.5，5，6，7，8，10，12，24 hours post-dose of Day 5，Day 19，Day 33，Day 47). 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?

On the ClinicalTrials.gov record for NCT04444011.

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 23 Jun 2020.

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