A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate

NCT ID: NCT05469854

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2024-12-02

Brief Summary

This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized study designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of 2 single ascending oral doses of linaprazan glurate. The study will explore the PK properties of linaprazan glurate and linaprazan as well as the cardiodynamic ECG effects, safety, and tolerability after the administration of single doses (300 mg, 600 mg, 200 mg and a final dose level of maximum 400 mg) of linaprazan glurate, using 25 mg base formulation (300 mg and 600 mg doses) and 25 mg and 100 mg HCl formulation (200 mg and final dose level of maximum 400 mg) oral tablets.

Conditions

Pharmacokinetics; Cardiodynamic ECG; Safety, and Tolerability; GERD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Linaprazan glurate

Oral administration as a single dose of 300 mg, 600 mg, 200 mg, and a final dose level of maximum 400 mg.

Group Type: EXPERIMENTAL

Linaprazan glurate

Intervention Type: DRUG

Linaprazan glurate base formulation, 25 mg oral tablets (300 mg and 600 mg doses).

Linaprazan glurate hydrochloride (HCl), 25 mg and 100 mg (as base) oral tablets (200 mg and final dose level of maximum 400 mg).

Placebo

Oral administration as a singel dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dose, oral tablets

Interventions

Linaprazan glurate

Linaprazan glurate base formulation, 25 mg oral tablets (300 mg and 600 mg doses).

Linaprazan glurate hydrochloride (HCl), 25 mg and 100 mg (as base) oral tablets (200 mg and final dose level of maximum 400 mg).

Intervention Type: DRUG

Placebo

Single dose, oral tablets

Intervention Type: DRUG

Other Intervention Names

X842

Eligibility Criteria

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

3. Body mass index ≥18.5 and ≤35.0 kg/m2.

4. Prospective subjects, as well as their partners, must agree to contraception requirements

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cinclus Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Rein-Hedin, MD

Role: PRINCIPAL_INVESTIGATOR

CTC Clinical Trial Consultants AB

Locations

CTC Clinical Trial Consultants AB

Uppsala, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Simon Rubinstein, MD, PhD

Role: CONTACT

simon.rubinstein@cincluspharma.com

+44 786 780 70 60

Facility Contacts

Måns Jergil, PhD

Role: primary

mans.jergil@ctc-ab.se

+4618303300

Other Identifiers

CX842A2104

Identifier Type: -

Identifier Source: org_study_id