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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03505853 |
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Date of registration:
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13/04/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP)
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Scientific title:
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A Drug-Drug Interaction Study to Investigate the Effect of Givosiran on the Pharmacokinetics (PK) of Midazolam, Caffeine, Losartan, Omeprazole, and Dextromethorphan in Patients With Acute Intermittent Porphyria (AIP) Who Are Asymptomatic High Excreters (ASHE) |
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Date of first enrolment:
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April 26, 2018 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03505853 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Nader Najafian, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Alnylam Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Hepatic Porphyria (AHP)
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Porphyria, Acute Intermittent
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Acute Intermittent Porphyria (AIP)
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Acute Porphyria
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Intervention(s)
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Drug: Givosiran
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Drug: 5-probe cocktail
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Primary Outcome(s)
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Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail
[Time Frame: Days 1 and 36]
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Secondary Outcome(s)
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Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail
[Time Frame: Days 1 and 36]
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Safety as evaluated by the proportion of subjects experiencing adverse events (AEs)
[Time Frame: Day 1 - Day 92]
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The pharmacodynamic (PD) effect of givosiran on urine levels of Porphobilinogen (PBG) in patients with AIP
[Time Frame: Days 1, 8, and 36]
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The pharmacodynamic (PD) effect of givosiran on urine levels of delta-aminolevulinic acid (ALA)
[Time Frame: Days 1, 8, and 36]
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Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail metabolites
[Time Frame: Days 1 and 36]
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Secondary ID(s)
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ALN-AS1-004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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