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Double-blind placebo-controlled cross-over MRI study to evaluate the effect of naloxegol and codeine on gastrointestinal motility and volumes
EU CTIS ID: 2024-512673-28-00
What this study is testing
To further understand the mechanism of action of naloxegol in healthy volunteers
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained
- 2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
- 3. HV is a man or woman aged 18 to 65 years, inclusive, at screening.
- 4. BMI 18-25
- 5. Normal stool pattern of between 3 defecations per day and 3 per week with a Bristol Stool Form Scale (BSFS) of 1, 2, 6 or 7 in less than 25% of defaecations.
- 6. HV has not used any opioid medication 14 days prior to randomization.
You likely can't join if
- 1. Participant has a history of diverticulitis, intestinal obstruction, stricture, toxic megacolon, GI perforation, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease)
- 6. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial a. current evidence of laxative abuse or history of drug abuse. b. current (within 14 days of randomization) or expected use of any narcotic or opioid containing agents, docusate, enemas, GI preparations (including antacids containing aluminum or magnesium, antidiarrheal agents, antinausea agents, antispasmodic agents, bismuth, or prokinetic agents) (see 5.3 prohibided concomitant medication). c. Intake of drugs that interfere with the GI motility and fluid balance for 1 month prior to the investigation (see 5.3 prohibided concomitant medication). d. Consumption of grapefruit (juice) or medication that interferes with Naloxegol (CYP3A4 inducers/blockers).
- 7. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
- 8. Participation in an interventional Trial with an investigational medicinal product (IMP) or device within 30 days prior to randomisation, or is currently enrolled in an investigational study
- 9. HV has a history of malignancy within 5 years before prescreening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
- 14. Subjects known to be ultrarapid metabolizers of CYP2D6
See the full eligibility criteria
Who can join
- 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained
- 2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
- 3. HV is a man or woman aged 18 to 65 years, inclusive, at screening.
- 4. BMI 18-25
- 5. Normal stool pattern of between 3 defecations per day and 3 per week with a Bristol Stool Form Scale (BSFS) of 1, 2, 6 or 7 in less than 25% of defaecations.
- 6. HV has not used any opioid medication 14 days prior to randomization.
- 7. Medications taken for the treatment of allergies, chronic medical conditions, and migraine headaches can be taken during this study (with the exception of opioids for acute treatment of migraines). HV must be on a stable dose of medication for chronic migraines or preventative therapy for at least 1 month at prescreening. HV on stable doses of antidepressants (i.e., for the 3 months prior to prescreening) will be allowed to participate in the study.
What rules you out
- 1. Participant has a history of diverticulitis, intestinal obstruction, stricture, toxic megacolon, GI perforation, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease)
- 6. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial a. current evidence of laxative abuse or history of drug abuse. b. current (within 14 days of randomization) or expected use of any narcotic or opioid containing agents, docusate, enemas, GI preparations (including antacids containing aluminum or magnesium, antidiarrheal agents, antinausea agents, antispasmodic agents, bismuth, or prokinetic agents) (see 5.3 prohibided concomitant medication). c. Intake of drugs that interfere with the GI motility and fluid balance for 1 month prior to the investigation (see 5.3 prohibided concomitant medication). d. Consumption of grapefruit (juice) or medication that interferes with Naloxegol (CYP3A4 inducers/blockers).
- 7. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
- 8. Participation in an interventional Trial with an investigational medicinal product (IMP) or device within 30 days prior to randomisation, or is currently enrolled in an investigational study
- 9. HV has a history of malignancy within 5 years before prescreening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
- 14. Subjects known to be ultrarapid metabolizers of CYP2D6
- 10. Participant has an unstable renal, hepatic, metabolic, or hematologic condition
- 11. Smoking on the day of the investigation and the day prior to it.
- 12. Non-removable piercings or metal implants
- 13. Known allergy towards the study medication
- 2. Participant has any of the following surgical history: a. Any abdominal surgery within the 3 months prior to prescreening; b. History of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy more than 3 months earlier are allowed).
- 3. Participant has asthma
- 4. Participant has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to prescreening
- 5. Any other disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.