Acute Intermittent Porphyria (AIP) Clinical Trial
Official title:
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)
Verified date | March 2019 |
Source | Alnylam Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | January 10, 2019 |
Est. primary completion date | November 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Clinical Trial Site | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Alnylam Pharmaceuticals |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail | Area under the concentration-time curve (AUC) | Days 1 and 36 | |
Primary | Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail | Maximum plasma concentration (Cmax) | Days 1 and 36 | |
Secondary | Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail metabolites | Area under the concentration-time curve (AUC) | Days 1 and 36 | |
Secondary | Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail metabolites | Maximum plasma concentration (Cmax) | Days 1 and 36 | |
Secondary | Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail | Terminal half-life (t1/2) | Days 1 and 36 | |
Secondary | Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail | Volume of distribution (V/F) | Days 1 and 36 | |
Secondary | The pharmacodynamic (PD) effect of givosiran on urine levels of delta-aminolevulinic acid (ALA) | Days 1, 8, and 36 | ||
Secondary | The pharmacodynamic (PD) effect of givosiran on urine levels of Porphobilinogen (PBG) in patients with AIP | Days 1, 8, and 36 | ||
Secondary | Safety as evaluated by the proportion of subjects experiencing adverse events (AEs) | Day 1 - Day 92 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05502133 -
Identification of Acute Intermittent Porphyria Modifying Genes
|
||
Terminated |
NCT03547297 -
INSIGHT-AHP: A Study to Characterize the Prevalence of Acute Hepatic Porphyria (AHP) in Patients With Clinical Presentation and History Consistent With AHP
|
||
Completed |
NCT01568554 -
Clinical Diagnosis of Acute Porphyria
|