Early Phase 1 Pancreatitis Trial, Recruiting NCT05771675 Sponsor: Cedars-Sinai Medical Center Condition: Pancreatitis
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Early Phase 1 Pancreatitis Trial, Recruiting

NCT05771675
Recruiting Early 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 aged 18 to 75 years at the time of joining the trial.
  • People who have been diagnosed with recurring acute pancreatitis or chronic pancreatitis that is not caused by gallstones, certain medications, injury, or an autoimmune condition.
  • People who are able to swallow tablets or capsules and are willing to take the study medication as directed.
  • People who are willing to follow all study procedures and be available for the full duration of the trial.
  • People who have signed and dated a consent form agreeing to take part.
  • People who have not had any surgery on their pancreas.
  • People who have not been taking a type of cholesterol-lowering medication called a statin for the past 6 months.
  • Women who could become pregnant must have been using a highly effective form of contraception for at least 1 month before joining, and must agree to continue using it during the trial and for 1 month afterward.
  • Men who could father a child must have been using condoms or another reliable contraception method for at least 1 month before joining, and must agree to continue during the trial and for 1 month afterward.

Who may not be able to join:

  • People who are currently pregnant or breastfeeding.
  • People whose pancreatitis was caused by an autoimmune condition, a medication, or a physical injury.
  • People who have a tumour in the pancreas, including certain types of cancer or cysts larger than 1 cm.
  • People who have cancer that has spread to the pancreas from another part of the body.
  • People who have had a solid organ transplant (such as a kidney or liver transplant) or who have HIV/AIDS.
  • People who have been diagnosed with poor pancreatic digestive function (exocrine insufficiency) that is not linked to the pancreatitis conditions listed in the eligibility criteria.
  • People who need to regularly take certain medications that could interact with the study drug, including itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, or verapamil.
  • People who have taken a cholesterol-lowering medication called simvastatin in the past 6 months.
  • People who have active liver disease.
  • People with a mental health condition, other medical illness, or ongoing substance use that the trial doctor believes would make it difficult to safely take part in the trial.
  • People who are currently in prison or detention.
  • People who are unable to follow the trial activities and requirements.
  • Women who could become pregnant must have a negative pregnancy test within 2 days before any research-related procedures, unless they are post-menopausal (no periods for 2 or more years) or have had certain surgical procedures that prevent pregnancy (confirm with trial site for details).

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
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Stephen Pandol, MD, Cedars-Sinai Medical Center

Phone: 3109671110

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
Early Phase 1
Sponsor
Cedars-Sinai Medical Center
Registry
ClinicalTrials.gov
Start date
24 October 2024
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Examine the feasibility and acceptability of testing the effect of simvastatin on health-related quality of life outcomes in patients with recurrent acute and chronic pancreatitis.

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