Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation

Pharmacokinetics Clinical Trial

— BA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05627518
• Other study ID #: CX842A2106
• Status: Completed
• Phase: Phase 1
• Start date: November 15, 2022
• Est. completion date: January 2, 2023

Study information

• Verified date: January 2023
• Source: Cinclus Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bioavailability
• Pharmacokinetics
• Safety

Intervention

Drug:
• Linaprazan glurate
100 mg

Locations

Country	Name	City	State
Slovenia	CRS d.o.o.	Ljubljana	Ukmarjeva Ulica 6

Sponsors (1)

Lead Sponsor	Collaborator
Cinclus Pharma AG

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)	Area under the plasma concentration vs. time curve (AUC) from time 0 to infinity (AUCinf)	pre dose, 0,25h, 0,5h, 1h, 1,25h, 1,5h, 2h, 3h, 4h, 6h, 8h, 12h, 14h, 20h, 24h, 36h, 48h and 72 h post dose
Primary	Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)	AUC from time 0 to the last measurable concentration (AUClast)	pre dose, 0,25h, 0,5h, 1h, 1,25h, 1,5h, 2h, 3h, 4h, 6h, 8h, 12h, 14h, 20h, 24h, 36h, 48h and 72 h post dose
Primary	Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)	Maximum plasma concentration (Cmax)	pre dose, 0,25h, 0,5h, 1h, 1,25h, 1,5h, 2h, 3h, 4h, 6h, 8h, 12h, 14h, 20h, 24h, 36h, 48h and 72 h post dose