Helicobacter PyloriPhase 1NCT02892409
TAK-438 Bismuth Drug Interaction Study
A Phase 1 study testing Clarithromycin, Amoxicillin and Tripotassium bismuth dicitrate in people with Helicobacter Pylori, run by Takeda at 1 site in South Korea.
Trial summary
To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and lansoprazole. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Clarithromycin, Amoxicillin and Tripotassium bismuth dicitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Sep 2016to 11 May 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HP positive participants.
- Has body mass index between greater than (>) 18 and less than equal to (<=) 30 kilogram per square meter (kg/m^2) and weighs greater than equal to (>=) 50 kilogram (kg).
- Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up call on Day 17.
Who cannot join
- Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular consumption of 21 units or more units per week) at any time prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study (up to Day 17).
- Has history of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome.
- Has undergone therapeutic upper gastrointestinal endoscopic therapy (example, endoscopic hemostasis or excision including biopsy) within 30 days prior to Screening.
- Has undergone major surgical procedures within the past 1 month or are scheduled to undergo surgical procedures that may affect gastric acid secretion (example, abdominal surgery, vagotomy, or craniotomy).
- Has a history of cancer, except basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin that has been in remission for at least 5 years prior to Day 1.
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- Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen at Screening.
- Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 6 weeks prior to Check-in. Cotinine test is positive at Screening or Check-in.
- Has poor peripheral venous access. Has donated or lost 450 milliliter (mL) or more of his blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1.
- Has abnormal Screening or Check-in laboratory values that suggest a clinically significant underlying disease or subject with the following laboratory abnormalities: alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin > the upper limit of normal (ULN).
- Has reduced renal function assessed by having an estimated glomerular filtration rate <90 milliliter per min per 1.73 square meter (mL/min/1.73 m^2) (as estimated by Chronic Kidney Disease-Epidemology Collaboration) at Screening or Check-in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of Quadruple Therapy (Bismuth, Clarithromycin, and Amoxicillin) With TAK-438 Versus Quadruple Therapy With Lansoprazole
To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and lansoprazole.
Read the detailed description
This is a phase 1, double-blind, parallel group study in participants with Helicobacter pylori (HP positive) who are, additionally, cytochrome P-450 (CYP)2C19 extensive metabolizers (EM) to evaluate the safety, tolerability and pharmacokinetics (PK) of a quadruple therapy with bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and lansoprazole. The study will enroll 30 participants.
The treatment phase consists of quadruple therapy twice daily (BID) with tripotassium bismuth dicitrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and TAK-438 (20 mg) (Group B) or quadruple therapy BID with tripotassium bismuth dicitrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg),and lansoprazole (30 mg) (Group A) from Days 1 to 14. Participants will be discharged on Day 15 after final PK blood samples are collected and all procedures performed.
This single-center will be conducted in Korea. Participants will remain confined to the study site from check-in (Day -1) through Day 15 and will followed up through call on Day 17 and return on Day 42 for a follow-up assessment.
- Conditions
- Helicobacter Pylori
- Being tested
- Clarithromycin, Amoxicillin, Tripotassium bismuth dicitrate, Lansoprazole, TAK-438
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
Clarithromycin tablets
AmoxicillinDrug
Amoxicillin capsules
Tripotassium bismuth dicitrateDrug
Tripotassium bismuth dicitrate tablets
LansoprazoleDrug
Lansoprazole capsules
TAK-438Drug
TAK-438 tablets
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycin + Amoxicillin + Bismuth + Lansoprazole | Active comparator | Clarithromycin 500 milligram (mg), tablets, orally, twice daily, along with amoxicillin 1000 mg capsules, orally, twice daily, tripotassium bismuth dicitrate 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14. Receives: Drug: Clarithromycin; Drug: Amoxicillin; Drug: Tripotassium bismuth dicitrate; Drug: Lansoprazole |
| Clarithromycin + Amoxicillin + Bismuth + TAK-438 | Experimental | Clarithromycin 500 mg, tablets, orally, twice daily, along with amoxicillin 1000 mg, capsules, orally, twice daily, tripotassium bismuth dicitrate 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14. Receives: Drug: Clarithromycin; Drug: Amoxicillin; Drug: Tripotassium bismuth dicitrate; Drug: TAK-438 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Measured: Baseline up to Day 17
Percentage of Participants Who Discontinue Due to an Adverse Event (AE)
Measured: Baseline up to Day 17
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose
Measured: Baseline up Day 15
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Measured: Baseline up to Day 15
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose
Measured: Baseline up to Day 15
Cmax: Maximum Observed Plasma Concentration for Bismuth
Measured: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Bismuth
Measured: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for Bismuth
Measured: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start5 Sep 2016
- Primary completion17 Apr 2017
- Study completion11 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892409
- Sponsor's protocol ID
- TAK-438_115
- Other IDs
- U1111-1179-5816, 02892409
- Status last verified
- Jun 2018
- First submitted
- 2 Sep 2016
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of Quadruple Therapy (Bismuth, Clarithromycin, and Amoxicillin) With TAK-438 Versus Quadruple Therapy With Lansoprazole
- ClinicalTrials.gov ID
- NCT02892409
- Acronym / sponsor ID
- TAK-438_115
- Conditions
- Helicobacter Pylori
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2016 (actual)
- Primary completion
- 17 Apr 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and lansoprazole.
Detailed description
This is a phase 1, double-blind, parallel group study in participants with Helicobacter pylori (HP positive) who are, additionally, cytochrome P-450 (CYP)2C19 extensive metabolizers (EM) to evaluate the safety, tolerability and pharmacokinetics (PK) of a quadruple therapy with bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and lansoprazole. The study will enroll 30 participants.
The treatment phase consists of quadruple therapy twice daily (BID) with tripotassium bismuth dicitrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and TAK-438 (20 mg) (Group B) or quadruple therapy BID with tripotassium bismuth dicitrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg),and lansoprazole (30 mg) (Group A) from Days 1 to 14. Participants will be discharged on Day 15 after final PK blood samples are collected and all procedures performed.
This single-center will be conducted in Korea. Participants will remain confined to the study site from check-in (Day -1) through Day 15 and will followed up through call on Day 17 and return on Day 42 for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clarithromycin + Amoxicillin + Bismuth + Lansoprazole | Active comparator | Drug: Clarithromycin, Drug: Amoxicillin, Drug: Tripotassium bismuth dicitrate, Drug: LansoprazoleClarithromycin 500 milligram (mg), tablets, orally, twice daily, along with amoxicillin 1000 mg capsules, orally, twice daily, tripotassium bismuth dicitrate 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14. |
| Clarithromycin + Amoxicillin + Bismuth + TAK-438 | Experimental | Drug: Clarithromycin, Drug: Amoxicillin, Drug: Tripotassium bismuth dicitrate, Drug: TAK-438Clarithromycin 500 mg, tablets, orally, twice daily, along with amoxicillin 1000 mg, capsules, orally, twice daily, tripotassium bismuth dicitrate 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- HP positive participants.
- Has body mass index between greater than (>) 18 and less than equal to (<=) 30 kilogram per square meter (kg/m^2) and weighs greater than equal to (>=) 50 kilogram (kg).
- Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up call on Day 17.
Key exclusion criteria (11 listed)
- Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular consumption of 21 units or more units per week) at any time prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study (up to Day 17).
- Has history of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome.
- Has undergone therapeutic upper gastrointestinal endoscopic therapy (example, endoscopic hemostasis or excision including biopsy) within 30 days prior to Screening.
- Has undergone major surgical procedures within the past 1 month or are scheduled to undergo surgical procedures that may affect gastric acid secretion (example, abdominal surgery, vagotomy, or craniotomy).
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 |
|---|---|---|
| ClarithromycinClarithromycin tablets | Drug | Clarithromycin + Amoxicillin + Bismuth + Lansoprazole, Clarithromycin + Amoxicillin + Bismuth + TAK-438 |
| AmoxicillinAmoxicillin capsules | Drug | Clarithromycin + Amoxicillin + Bismuth + Lansoprazole, Clarithromycin + Amoxicillin + Bismuth + TAK-438 |
| Tripotassium bismuth dicitrateTripotassium bismuth dicitrate tablets | Drug | Clarithromycin + Amoxicillin + Bismuth + Lansoprazole, Clarithromycin + Amoxicillin + Bismuth + TAK-438 |
| LansoprazoleLansoprazole capsules | Drug | Clarithromycin + Amoxicillin + Bismuth + Lansoprazole |
| TAK-438TAK-438 tablets | Drug | Clarithromycin + Amoxicillin + Bismuth + TAK-438 |
Primary outcome
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Baseline up to Day 17
Percentage of Participants Who Discontinue Due to an Adverse Event (AE)
Time frame: Baseline up to Day 17
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose
Time frame: Baseline up Day 15
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Time frame: Baseline up to Day 15
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose
Time frame: Baseline up to Day 15
Cmax: Maximum Observed Plasma Concentration for Bismuth
Time frame: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Bismuth
Time frame: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for Bismuth
Time frame: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Takeda
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 Clarithromycin, Amoxicillin and Tripotassium bismuth dicitrate in people with Helicobacter Pylori, run by Takeda at 1 site in South Korea.
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 3 inclusion and 11 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 3 Jan 2019. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) (time frame: Baseline up to Day 17). The study lists 8 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 3 Jan 2019.