Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects

Cinclus Pharma

Status and phase: Completed; Phase 1

Conditions: GERD

Treatments: Drug: linaprazan glurate 25 mg QD; Drug: linaprazan glurate 25 mg BID; Drug: linaprazan glurate 50 mg BID; Drug: linaprazan glurate 75 mg BID; Drug: linaprazan glurate 75 mg QD; Drug: linaprazan glurate 50 mg QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT05742984

CX842A2107

Details and patient eligibility

About

This is a Phase I, single-center, open label parallel-group, randomized study designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD, by continuous intragastric pH measurment), safety and tolerability of single and repeated oral doses of linaprazan glurate in 3 different dose levels given once- (QD) or twice daily (BID), for 14 days, with an additional single dose after 2, 4 or 6 days of drug holiday. The population will include healthy male and female subjects.

The subjects will be followed up to 28 days post IMP dosing.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Willing and able to give written informed consent for participation in the study.
2. Healthy male or female subject 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, physical findings, vital signs, ECGs, or laboratory values at the time of screening, as judged by the Investigator.

Exclusion criteria

1. Female subjects of childbearing potential (defined as all subjects physiologically capable of becoming pregnant)
2. Male subjects with a partner of childbearing potential
3. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
4. History of GERD or clinically significant acid reflux, as judged by the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 6 patient groups

Group 1: 25 mg linaprazan glurate QD

Experimental group

Description:

25 mg (one 25 mg oral tablet) linaprazan glurate once daily (QD) for 14 days

Treatment:

Drug: linaprazan glurate 25 mg QD

Group 2: 50 mg Linaprazan Glurate QD

Experimental group

Description:

50 mg (two 25 mg oral tablets) linaprazan glurate once daily (QD) for 14 days

Treatment:

Drug: linaprazan glurate 50 mg QD

Group 3: 75 mg Linaprazan Glurate QD

Experimental group

Description:

75 mg (three 25 mg oral tablet) linaprazan glurate once daily (QD) for 14 days

Treatment:

Drug: linaprazan glurate 75 mg QD

Group 4: 25 mg Linaprazan Glurate BID

Experimental group

Description:

25 mg (one 25mg oral tablet) linaprazan glurate twice daily (BID) for 14 days

Treatment:

Drug: linaprazan glurate 25 mg BID

Group 5: 50 mg Linaprazan Glurate BID

Experimental group

Description:

50 mg (two 25 mg oral tablets) linaprazan glurate twice daily (BID) for 14 days

Treatment:

Drug: linaprazan glurate 50 mg BID

Group 6: 75 mg Linaprazan Glurate BID

Experimental group

Description:

75 mg (three 25 mg oral tablet) linaprazan glurate twice daily (BID) for 14 days

Treatment:

Drug: linaprazan glurate 75 mg BID