TAK-438 Bismuth Drug Interaction Study

NCT02892409 | Completed Phase 1 Results

• 3 other identifiers: TAK-438_115U1111-1179-581602892409
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)

  Baseline up to Day 17

• Percentage of Participants Who Discontinue Due to an Adverse Event (AE)

  Baseline up to Day 17

• Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose

  Baseline up Day 15

• Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose

  Baseline up to Day 15

• Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose

  Baseline up to Day 15

• Cmax: Maximum Observed Plasma Concentration for Bismuth

  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

  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

  Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose

Study Arms (2)

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.

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.

Drug: Clarithromycin; Drug: Amoxicillin; Drug: Tripotassium bismuth dicitrate; Drug: TAK-438

Interventions

Clarithromycin DRUG

Clarithromycin tablets

Clarithromycin + Amoxicillin + Bismuth + Lansoprazole; Clarithromycin + Amoxicillin + Bismuth + TAK-438

Amoxicillin DRUG

Amoxicillin capsules

Clarithromycin + Amoxicillin + Bismuth + Lansoprazole; Clarithromycin + Amoxicillin + Bismuth + TAK-438

Tripotassium bismuth dicitrate DRUG

Tripotassium bismuth dicitrate tablets

Clarithromycin + Amoxicillin + Bismuth + Lansoprazole; Clarithromycin + Amoxicillin + Bismuth + TAK-438

Lansoprazole DRUG

Lansoprazole capsules

Clarithromycin + Amoxicillin + Bismuth + Lansoprazole

TAK-438 DRUG

TAK-438 tablets

Clarithromycin + Amoxicillin + Bismuth + TAK-438

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Interventions

Clarithromycin; Amoxicillin; bismuth tripotassium dicitrate; Lansoprazole; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 8, 2016
• Study Start: September 5, 2016
• Primary Completion: April 17, 2017
• Study Completion: May 11, 2017
• Last Updated: January 3, 2019
• Results First Posted: January 3, 2019

Record last verified: 2018-06

Locations

KR (1)