Clinical trial NCT05742984: Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects
Official title: A Phase 1, Open Label, Randomized, Parallel-group, Single Center Study to Investigate Pharmacokinetics and Pharmacodynamics (Intragastric pH) of Linaprazan Glurate/Linaprazan After Single and 14 Days'Repeated Oral Administration of Linaprazan Glurate to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: GERD
Lead sponsor: Cinclus Pharma Holding AB
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I, single-center, open label parallel-group, randomized study designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD, by continuous intragastric pH measurment), safety and tolerability of single and repeated oral doses of linaprazan glurate in 3 different dose levels given once- (QD) or twice daily (BID), for 14 days, with an additional single dose after 2, 4 or 6 days of drug holiday. The population will include healthy male and female subjects.

The subjects will be followed up to 28 days post IMP dosing.


Eligibility criteria: Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.
2. Healthy male or female subject aged 18 to 65 years, inclusive.
3. Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
4. Medically healthy, without abnormal clinically significant medical history, physical findings, vital signs, ECGs, or laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

1. Female subjects of childbearing potential (defined as all subjects physiologically capable of becoming pregnant)
2. Male subjects with a partner of childbearing potential
3. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
4. History of GERD or clinically significant acid reflux, as judged by the Investigator.

Primary outcomes:
measure: AUC0-24h Linaprazan (QD)
timeFrame: Day 1 and Day 14
measure: AUC0-12, 12-24h Linaprazan (BID)
timeFrame: Day 1 and Day 14
measure: Cmax Linaprazan (QD)
timeFrame: Day 1 and day 14
measure: Cmax Linaprazan (BID)
timeFrame: Day 1 and day 14
measure: AUC0-24h Linaprazan Glurate (QD)
timeFrame: Day 1 and day 14
measure: AUC0-12h, 12-24h Linaprazan Glurate (BID)
timeFrame: Day 1 and Day 14
measure: Cmax Linaprazan Glurate (QD)
timeFrame: Day 1 and day 14
measure: Cmax Linaprazan Glurate (BID)
timeFrame: Day 1 and day 14
measure: Percentage of Time Gastric pH >4 Over a 24-hour Monitoring Period (Holding Time Ratio, HTR)
timeFrame: Day 1 and day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: CRS d.o.o,Ukmarjeva ulica 6
Study officials:
affiliation: CRS d.o.o Ljubljana, Ukmarjeva Ulica 6, Slovenia, 1000 Contact: Tanja Turk, M.pharm +38651619388 tanja.turk@crs.si
name: Tanja Turk, M.Pharm
role: STUDY_DIRECTOR
References: