A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients … (NCT03505853) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP)
Sweden10 participantsStarted 2018-04-26
Plain-language summary
The purpose of this study is to evaluate the effect of givosiran on the pharmacokinetics of the 5-probe cocktail of midazolam, caffeine, losartan, omeprazole, and dextromethorphan, and their metabolites, in asymptomatic patients with Acute Intermittent Porphyria.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 to 65 years old
* Weight between 45kg and 110kg, inclusive, if male
* Weight between 45kg and 100 kg, inclusive, if female
* Diagnosis of acute intermittent porphyria (AIP)
* Elevated urine PBG level
* Not be pregnant or breast feeding, and must be willing to use a highly effective method of contraception
Exclusion Criteria:
* Clinically significant abnormal laboratory results
* Experienced an acute porphyria attack within past 12 months
* History of multiple drug allergies, intolerances or sensitivities
* History of recurrent pancreatitis
* Received an experimental drug, within 3 months of dosing
* Donated or lost an excessive amount of blood within 60 days of dosing
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail
Timeframe: Days 1 and 36
2
Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail