Phase 1
Completed N=30
TAK-438 Bismuth Drug Interaction Study
Helicobacter Pylori
Source: ClinicalTrials.gov NCT02892409 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) — 53.3; 66.7 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) |
53.3; 66.7 | — |
| PRIMARY Percentage of Participants Who Discontinue Due to an Adverse Event (AE) |
6.7; 0.0 | — |
| PRIMARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose |
0.0; 6.7; 0.0; 6.7 | — |
| PRIMARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose |
0.0; 6.7; 6.7; 6.7; 6.7; 6.7 | — |
| PRIMARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose |
0.0; 6.7 | — |
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Bismuth |
28.08; 30.14 | — |
| PRIMARY AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Bismuth |
103.0; 111.1 | — |
| PRIMARY Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for Bismuth |
497300; 537600 | — |
Eligibility Criteria
Inclusion Criteria
- HP positive participants.
- Has body mass index between greater than (>) 18 and less 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02892409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.