A Study to Investigate the Effect of Linaprazan Glurate on the Pharmacokinetics of Amoxicillin

NCT07308041 | Completed Phase 1

• 1 other identifier: CX842B2111
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, single arm, single-center Phase I trial designed to evaluate the effect of seven days repeated oral doses of linaprazan glurate on the pharmacokinetics (PK) of repeated doses of amoxicillin in healthy male and female participants

Conditions

Drug Interaction; GERD (Gastroesophageal Reflux Disease); Safety, and Tolerability

Outcome Measures

Primary Outcomes (4)

• Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (AUC)

  Geometric mean ratio Day 8/Day 1 for amoxicillin Area Under the Plasma Concentration vs. Time Curve (AUC)

  Day 1 and Day 8

• Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (Cmax)

  Geometric mean ratio Day 8/Day 1 for amoxicillin Cmax

  Day 1 and Day 8

• Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (Tmax)

  Amoxicillin Tmax

  Day 1 and Day 8

• Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (CL/F)

  Amoxicillin apparent oral clearance (CL/F)

  Day 1 and Day 8

Study Arms (1)

Linaprazan glurate

EXPERIMENTAL

Oral administration for seven (7) days.

Drug: Drug Drug Interaction

Interventions

Drug Drug Interaction DRUG

The intervention phase consists of 2 periods: in period 1, the pharmacokinetics (PK) of amoxicillin will be evaluated in the absence of linaprazan glurate, in period 2, a potential effect of linaprazan glurate on the PK of amoxicillin will be evaluated as well as the PK of linaprazan glurate following co-administration of amoxicillin.

Linaprazan glurate

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to give written informed consent for participation in the trial.
• Healthy male or female participant aged 18 to 64 years, inclusive.
• Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit.
• Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.

You may not qualify if:

• Female participants of childbearing potential (defined as all participants physiologically capable of becoming pregnant) unless they agree to use one of the following highly effective methods of contraception (failure rate of \<1%) from 2 weeks prior to the first dose until the end-of-trial visit:
• Sterilization of a male partner, defined as vasectomy, at least six months prior to screening.
• Intra-uterine device (non-hormonal or copper IUD).
• Double-barrier methods of contraception, i.e., condoms in combination with occlusive cap with contraceptive gel.
• Male participants with a partner of childbearing potential, unless they agree to use one of the following methods of contraception from two weeks prior to the first dose until the end-of-trial visit:
• Vasectomy at least six months prior to screening.
• Condoms. Female partners of childbearing potential must then agree to concurrently use a highly effective method of contraception.
• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
• Any clinically significant illness, medical/surgical procedure or trauma within four weeks of the first administration of IMP.
• Positive result for H.pylori antibodies at the time of the screening visit.

Sponsors & Collaborators

• Cinclus Pharma Holding AB: lead

Study Sites (1)

CTC Clinical Trial Consultants AB

Uppsala, 752 37, Sweden

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: November 11, 2025
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: February 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)