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Completed

NCT Number: NCT05742984

Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects

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.

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRS d.o.o,Ukmarjeva ulica 6

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to give written informed consent for participation in the study.
  • Healthy male or female subject aged 18 to 65 years, inclusive.
  • Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
  • 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

  • Female subjects of childbearing potential (defined as all subjects physiologically capable of becoming pregnant)
  • Male subjects with a partner of childbearing potential
  • 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.
  • History of GERD or clinically significant acid reflux, as judged by the Investigator.

Treatment and study plan

linaprazan glurate 25 mg QD

Drug

The subjects will receive 25 mg dose in the evening, in a non-fasted condition 30 minutes after the evening meal, for 14 days. Subjects are to follow a standardized food intake schedule.

After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more in the evening (non-fasted).

linaprazan glurate 50 mg QD

Drug

The subjects will receive 50 mg dose in the evening, in a non-fasted condition 30 minutes after the evening meal, for 14 days. Subjects are to follow a standardized food intake schedule.

After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more in the evening (non-fasted).

linaprazan glurate 75 mg QD

Drug

The subjects will receive 75 mg dose in the evening, in a non-fasted condition 30 minutes after the evening meal, for 14 days. Subjects are to follow a standardized food intake schedule.

After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more in the evening (non-fasted).

linaprazan glurate 25 mg BID

Drug

The subjects will receive 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects will be fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, are allowed as desired, except for 1 hour before and 30 minutes after dosing. The second daily dose will be administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more (in fasted condition in the morning, non-fasted in the evening).

linaprazan glurate 50 mg BID

Drug

The subjects will receive 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects will be fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, are allowed as desired, except for 1 hour before and 30 minutes after dosing. The second daily dose will be administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more (in fasted condition in the morning, non-fasted in the evening).

linaprazan glurate 75 mg BID

Drug

The subjects will receive 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects will be fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, are allowed as desired, except for 1 hour before and 30 minutes after dosing. The second daily dose will be administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects are to follow a standardized food intake schedule. After a drug holiday period of either 2, 4 or 6 days, linaprazan glurate will be given once more (in fasted condition in the morning, non-fasted in the evening).

Primary outcomes

  1. AUC0-24h Linaprazan (QD)

    Time frame: Day 1 and Day 14

    Linaprazan area under the plasma concentration curve, from 0 to 24h post dose on Day 1 and Day 14. QD groups only.

  2. AUC0-12, 12-24h Linaprazan (BID)

    Time frame: Day 1 and Day 14

    Linaprazan area under the plasma concentration curve, from 0 to 12h and 12-24h post dose on Day 1 and Day 14. BID groups only.

  3. Cmax Linaprazan (QD)

    Time frame: Day 1 and day 14

    Linaprazan maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.

  4. Cmax Linaprazan (BID)

    Time frame: Day 1 and day 14

    Linaprazan maximum plasma concentration 0-12h, and 12-24h post dose for BID groups, at day 1 and day 14.

  5. AUC0-24h Linaprazan Glurate (QD)

    Time frame: Day 1 and day 14

    Linaprazan glurate area under the plasma concentration curve, from 0-24h post dose on Day 1 and Day 14. QD groups only.

  6. AUC0-12h, 12-24h Linaprazan Glurate (BID)

    Time frame: Day 1 and Day 14

    Linaprazan glurate area under the plasma concentration curve, from 0 to 12h and 12-24h post dose on Day 1 and Day 14. BID groups only.

  7. Cmax Linaprazan Glurate (QD)

    Time frame: Day 1 and day 14

    Linaprazan glurate maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.

  8. Cmax Linaprazan Glurate (BID)

    Time frame: Day 1 and day 14

    Linaprazan glurate maximum plasma concentration 0-12h and 12-24h post dose for BID groups, at day 1 and day 14.

  9. Percentage of Time Gastric pH >4 Over a 24-hour Monitoring Period (Holding Time Ratio, HTR)

    Time frame: Day 1 and day 14

    Percentage of time gastric pH >4 at Days 1 and 14 over a 24-hour monitoring period following linaprazan glurate administration.

    Intragastric pH was measured every second with an intragastric probe. The measurements were compressed into 10-minute median intervalls before calculating the % of time with intragastric >pH 4 (HTR). The HTR is presented with descriptive statistics, by dosing group.

Sponsors and collaborators

Lead sponsor

Cinclus Pharma Holding AB

Industry

Registry information

Official study title

A Phase 1, Open Label, Randomized, Parallel-group, Single Center Study to Investigate Pharmacokinetics and Pharmacodynamics (Intragastric pH) of Linaprazan Glurate/Linaprazan After Single and 14 Days'Repeated Oral Administration of Linaprazan Glurate to Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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