A Phase I Study to Investigate the Pharmacokinetics and ECG Effects of Two Single Ascending Doses of Linaprazan Glurate Given as Oral Tablets to Healthy Subjects

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Sweden
CTC Clinical Trial Consultants AB
RECRUITING
Uppsala
Contact Information
Primary
Simon Rubinstein, MD, PhD
simon.rubinstein@cincluspharma.com
+44 786 780 70 60
Time Frame
Start Date: 2022-07-13
Estimated Completion Date: 2024-12-02
Participants
Target number of participants: 113
Treatments
Experimental: Linaprazan glurate
Oral administration as a single dose of 300 mg, 600 mg, 200 mg, and a final dose level of maximum 400 mg.
Placebo_comparator: Placebo
Oral administration as a singel dose
Sponsors
Leads: Cinclus Pharma AG

This content was sourced from clinicaltrials.gov

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