Drug Interaction, GERD (Gastroesophageal Reflux Disease), Safety, and Tolerability
Conditions
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
Detailed description
Participants in the trial will attend three visits to the clinical research unit (CRU) and a telephone follow-up visit. Eligible participants will be admitted to the CRU in the evening of Day -1 and will remain at the CRU until the morning of Day 2 In the morning of Day 1, after pre-dose assessments, a dose of amoxicillin will be administered followed by 24 hours PK blood sampling for determination of amoxicillin plasma concentrations. Safety will be followed up throughout the 24 hours. In the morning of Day 2, after the 24-hour amoxicillin PK sample and safety assessments, the first linaprazan glurate will be administered to the participants. The participants will then continue to take linaprazan glurate (Day 2 to Day 8). The participants will be admitted to the CRU in the afternoon of Day 6 and will remain at the CRU until the morning of Day 9. PK samples for determination of linaprazan glurate and linaprazan in plasma will be collected for 24 hours at Day 7. In the morning of Day 8, the participants will be administered a new dose of amoxicillin together with the dose of linaprazan glurate, which will be followed by 24 hours PK sampling for determination of amoxicillin, linaprazan glurate and linaprazan plasma concentrations. The participants will leave the CRU after the 24-hour PK sample and safety assessments. A final end-of-trial telephone call will take place seven days (±two days) after the final dosing on Day 8.
Interventions
DRUGDrug Drug Interaction
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.
Sponsors
Cinclus Pharma Holding AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * Prospective participants, as well as their partners, must agree to the contraception requirements described in
Exclusion criteria
1 and 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (AUC) | Day 1 and Day 8 | Geometric mean ratio Day 8/Day 1 for amoxicillin Area Under the Plasma Concentration vs. Time Curve (AUC) |
| Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (Cmax) | Day 1 and Day 8 | Geometric mean ratio Day 8/Day 1 for amoxicillin Cmax |
| Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (Tmax) | Day 1 and Day 8 | Amoxicillin Tmax |
| Characterization of the PK of amoxicillin following a repeated dose before and after repeated administration of linaprazan glurate (CL/F) | Day 1 and Day 8 | Amoxicillin apparent oral clearance (CL/F) |
Countries
Sweden
Outcome results
None listed