Does adding YF476 to amoxicillin and clarithromycin aid eradication of H. pylori from healthy carriers? - YF476 and H. pylori

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002137-37-GB

Enrollment

Registered

2007-05-30

Start date

2007-07-13

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H pylori carriage in healthy adults MedDRA version: 9.1 Level: LLT Classification code 10063593 Term: Helicobacter pylori identification test positive

Interventions

Product Name: YF476 Product Code: YF476 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Proposed INN = grantamide CAS Number: 155488-25-8 Current Sponsor code: YF476 Concentration unit: mg mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Asymptomatic H. pylori-positive healthy men or women * Aged 18–70 years * Willing to use reliable methods of contraception, or of non-childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * Clinically relevant abnormal medical history or concurrent medical condition * QTc > 450 msec * Severe adverse reaction to any drug, in particular penicillin sensitivity * Concomitant medication (over-the-counter medication within previous 7 days; treatment with a proton pump inhibitor (PPI), H2-receptor antagonist or antibiotics in the last 3 months; other prescribed medication in last 28 days) * Participation in other clinical trials within the previous 3 months * Drug or alcohol abuse * Pregnancy, risk of pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to assess if adding YF476 to amoxicillin and clarithromycin therapy increases the eradication rate of H. pylori in healthy carriers.;Secondary Objective: The secondary objectives of the study are to: * assess the tolerability and safety of triple therapy: YF476, amoxicillin (Amoxil), and clarithromycin (Klaricid); and * obtain the pharmacokinetic parameters of YF476, clarithromycin and amoxicillin after dual and triple therapy, and seek evidence of pharmacokinetic interaction.;Primary end point(s): Breath test for H. pylori	—

Measure

Time frame

Main Objective: The primary objective of the study is to assess if adding YF476 to amoxicillin and clarithromycin therapy increases the eradication rate of H. pylori in healthy carriers.;Secondary Objective: The secondary objectives of the study are to: * assess the tolerability and safety of triple therapy: YF476, amoxicillin (Amoxil), and clarithromycin (Klaricid); and * obtain the pharmacokinetic parameters of YF476, clarithromycin and amoxicillin after dual and triple therapy, and seek evidence of pharmacokinetic interaction.;Primary end point(s): Breath test for H. pylori

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026