Clinical trial NCT05627518: Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
Official title: A Randomized, Single Dose, Crossover Study in Healthy Volunteers to Investigate the Relative Bioavailability of Linaprazan for a New Oral Tablet Formulation of Linaprazan Glurate, and to Assess the Effect of Food on the Pharmacokinetics of Linaprazan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Bioavailability
Pharmacokinetics
Lead sponsor: Cinclus Pharma Holding AB
Sponsor class: INDUSTRY
First posted: 2022-11-25
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a previously studied oral tablet formulation under fasting conditions, and to assess the effect of a high fat, high calorie meal on the pharmacokinetics (PK) of linaprazan glurate and the active substance linaprazan after the administration of the new oral tablet formulation.


Eligibility criteria: Main Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.
2. Healthy male or female 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
5. Female subjects of childbearing potential, as well as their partners and male subjects and their partners, who agree to using methods of contraception
6. Willing and able to consume the high-fat, high calorie breakfast

Exclusion Criteria:

1. Female subjects of childbearing potential unless they agree to use highly effective methods of contraception (failure rate of \<1%) from 2 weeks prior to dosing until the end-of-study visit.
2. Male subjects with a partner of childbearing potential, unless they agree to use method of contraception from 2 weeks prior to dosing until the end-of-study visit.History of or current clinically significant disease as defined in the protocol
3. History of or current clinically significant disease as defined in the protocol.
4. History of GERD, significant acid reflux.
5. Subjects who are pregnant, currently breastfeeding, or intend to become pregnant (female subjects) or father a child (male subjects) during the course of the study (i.e., from screening to end of study visit).

Primary outcomes:
measure: Relative Bioavailability of Linaprazan Comparing Test Formulation vs. Reference Formulation of Linaprazan Glurate. Ratios of AUCinf and AUClast
timeFrame: From pre-dose up to 72 h post dose
measure: Relative Bioavailability of Linaprazan Comparing Test Formulation vs. Reference Formulation of Linaprazan Glurate. Ratio of Cmax
timeFrame: From pre-dose up to 72 h post dose
measure: Relative Bioavailability of Linaprazan Test Formulation in Fed vs. Fasting Conditions, Based on the Means Ratios for AUCinf and AUClast
timeFrame: From pre-dose up to 72 h post dose
measure: Relative Bioavailability of Linaprazan Test Formulation in Fed vs. Fasting Conditions, Based on the Means Ratios for Cmax
timeFrame: From pre-dose up to 72 h post dose
Secondary outcomes:
measure: Relative Bioavailability of Linaprazan Glurate for the Test Formulation vs. Reference Formulation of Linaprazan Glurate, Based on the Means Ratios of PK Parameters.
timeFrame: From pre-dose up to 72 h post dose
measure: Relative Bioavailability of Linaprazan Glurate Comparing Test Formulation vs. Reference Formulation of Linaprazan Glurate. Ratio of Cmax
timeFrame: From pre-dose up to 72 h post dose
measure: Relative Bioavailability of Linaprazan Glurate in Fed vs. Fasting Conditions, Based on the Means Ratios for AUCinf, AUClast
timeFrame: From pre-dose up to 72 h post dose
measure: Relative Bioavailability of Linaprazan Glurate in Fed vs. Fasting Conditions, Based on the Means Ratio of Cmax
timeFrame: From pre-dose up to 72 h post dose
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: CRS d.o.o.
state: Ukmarjeva Ulica 6
Study officials:
References: