Phase 1 Gastro-oesophageal Reflux Disease Trial, Recruiting NCT05469854 Sponsor: Cinclus Pharma Holding AB Condition: Gastro-oesophageal Reflux Disease
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Phase 1 Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT05469854
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to give written consent to participate in the study.
  • Healthy men or women between 18 and 65 years of age.
  • People with a body mass index (BMI) between 18.5 and 35.0.
  • People and their partners who agree to follow the study's contraception requirements.

Who may not be able to join:

  • Women who could become pregnant, unless they agree to use a highly effective form of contraception (with a failure rate of less than 1%) starting two weeks before receiving the study drug and continuing until the final study visit.
  • Men whose partner could become pregnant, unless they agree to use contraception starting two weeks before receiving the study drug and continuing until the final study visit.
  • People who have a history of, or currently have, a significant medical condition as defined by the study protocol (confirm with trial site).
  • People who have a history of gastroesophageal reflux disease (GERD) or significant acid reflux.
  • Women who are currently pregnant or breastfeeding, or anyone who plans to become pregnant or father a child at any point during the study period.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Erik Rein-Hedin, MD, CTC Clinical Trial Consultants AB

Phone: +32 470214020

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Cinclus Pharma Holding AB
Registry
ClinicalTrials.gov
Start date
13 July 2022
Est. completion
30 November 2026

Where this trial is recruiting

🇸🇪 Sweden

Primary endpoints

Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUCinf); Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (AUClast); Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (Cmax); Measurement of pharmacokinetic profile of linprazan glurate and linaprazan (T1/2); Measurement of Cardiodynamic ECG (QTcF); Measurement of Cardiodynamic ECG (heart rate); Measurement of Cardiodynamic ECG (PR interval); Measurement of Cardiodynamic ECG (QRS interval); Measurement of Cardiodynamic ECG (placebo-corrected QTcF); Measurement of Card...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov