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

NCT05469854 | Recruiting Phase 1

• 1 other identifier: CX842A2104
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (15)

• Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf)

  To assess the Area under the plasma concentration vs. time curve (AUC) from time 0 to infinity (AUCinf)

  Up to 24 hours

• Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast)

  To assess the AUC from time 0 to the last measurable concentration (AUClast)

  Up to 24 hours

• Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax)

  To assess the Maximum plasma concentration (Cmax)

  Up to 24 hours

• Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2)

  To assess the Terminal elimination half-life (T1/2)

  Up to 24 hours

• Measurement of Cardiodynamic ECG (QTcF)

  To assess the change from baseline in QTcF

  Up to 24 hours

• Measurement of Cardiodynamic ECG (heart rate)

  To assess the change from baseline in heart rate

  Up to 24 hours

• Measurement of Cardiodynamic ECG (PR interval)

  To assess the change from baseline in PR interval

  Up to 24 hours

• Measurement of Cardiodynamic ECG (QRS interval)

  To assess the change from baseline in QRS interval

  Up to 24 hours

• Measurement of Cardiodynamic ECG (placebo-corrected QTcF)

  To assess the change from baseline in placebo-corrected QTcF

  Up to 24 hours

• Measurement of Cardiodynamic ECG (placebo-corrected heart rate)

  To assess the change from baseline in placebo-corrected heart rate

  Up to 24 hours

• Measurement of Cardiodynamic ECG (placebo-corrected PR interval)

  To assess the change from baseline in placebo-corrected PR interval

  Up to 24 hours

• Measurement of Cardiodynamic ECG (placebo-corrected QRS interval)

  To assess the change from baseline in placebo-corrected QRS interval

  Up to 24 hours

• Measurement of Cardiodynamic ECG (categorical outliers)

  Number of categorical outliers for ECG parameters (QTcF, HR, PR interval, QRS interval)

  Up to 24 hours

• Measurement of Cardiodynamic ECG (changes of T-wave)

  Frequency of treatment emergent changes of T-wave abnormalities

  Up to 24 hours

• Measurement of Cardiodynamic ECG (changes of U-wave)

  Frequency of treatment emergent changes of U-wave abnormalities

  Up to 24 hours

Study Arms (2)

Linaprazan glurate

EXPERIMENTAL

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

Drug: Linaprazan glurate

Placebo

PLACEBO COMPARATOR

Oral administration as a singel dose

Drug: Placebo

Interventions

Linaprazan glurate 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).

Also known as: X842

Linaprazan glurate

Placebo DRUG

Single dose, oral tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give written informed consent for participation in the study.
• Healthy male or female aged 18 to 65 years
• Body mass index ≥18.5 and ≤35.0 kg/m2.
• Prospective subjects, as well as their partners, must agree to contraception requirements

You may not qualify if:

• 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.
• 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
• History of or current clinically significant disease as defined in the protocol.
• History of GERD, significant acid reflux.
• 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).

Sponsors & Collaborators

• Cinclus Pharma AG: lead

Study Sites (1)

CTC Clinical Trial Consultants AB

Uppsala, SE-75237, Sweden

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Erik Rein-Hedin, MD

  CTC Clinical Trial Consultants AB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Rubinstein, MD, PhD

CONTACT

+44 786 780 70 60; simon.rubinstein@cincluspharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 22, 2022
• Study Start: July 13, 2022
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

SE (1)