Phase 1 Cystic Fibrosis Trial, Recruiting
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 sign a consent form and take part in all study activities for the full duration of the trial.
- People aged 18 or older at the time of consent.
- People with a confirmed diagnosis of cystic fibrosis (CF), based on a sweat test or genetic testing.
- People who need pancreatic enzyme supplements because their pancreas does not produce enough digestive enzymes.
- People who have been found to have abnormal blood sugar levels through a specific glucose tolerance test, or who have already been diagnosed with cystic fibrosis-related diabetes (CFRD).
- People with CFRD who do not have high fasting blood sugar levels may be eligible without additional requirements.
- People with CFRD who do have high fasting blood sugar levels (or who use basal insulin) must also have an HbA1c (a measure of average blood sugar over time) of 8% or below, and a C-peptide level (a marker of insulin production) of at least 1.2 ng/mL (confirm with trial site).
- Women who could become pregnant must be using an accepted highly effective form of contraception during the study — accepted methods include the pill, IUDs, implants, injections, or barrier devices used with spermicide; condoms alone are not accepted.
Who may not be able to join:
- People who have a type of diabetes not related to CF, such as type 1 diabetes.
- People who are pregnant or breastfeeding; a negative pregnancy test will be required before joining.
- People who have had a lung flare-up requiring IV antibiotics or steroid tablets/injections within the 4 weeks before the study starts.
- People currently taking certain medications that affect how the body processes drugs — these include some antifungal, antibiotic, and antiviral medicines, among others (confirm with trial site for a full list).
- People who have used herbal remedies, including St. John's Wort, within 14 days before starting the study.
- People who have changed their CF modulator therapy (a type of CF treatment) within the past 3 months.
- People who have had a painful pancreas flare-up (pancreatitis) with symptoms within the past year.
- People who have previously had a lung, liver, or other solid organ transplant.
- People with significantly reduced kidney function or high potassium levels in the blood.
- People with significantly elevated liver function test results.
- People with uncontrolled high triglyceride or cholesterol levels in the blood.
- People with significantly high uric acid levels in the blood.
- People with anaemia (low haemoglobin/low red blood cell levels).
- People with any other health condition that, in the view of the study doctor, could affect the results or safety of the trial.
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.
Contact this trial
Principal Investigator: Michael R Rickels, MD, MS, University of Pennsylvania
Phone: 215-746-2081
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
Where this trial is recruiting
Primary endpoints
Drug concentrations (PK; Cmax); Glucose tolerance (PD)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.