A Phase 1 interventional study of Givosiran and 5-probe cocktail in Acute Intermittent Porphyria (AIP), Acute Hepatic Porphyria (AHP) and Porphyria, Acute Intermittent, sponsored by Alnylam Pharmaceuticals. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Alnylam Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
41 studies on the registry are indexed under Porphyrias; 3 are open to participants now.
This study's enrollment of 10 is below the median of 24 across 22 interventional studies indexed under Porphyrias.
Browse Porphyrias studies →Alnylam Pharmaceuticals is the lead sponsor of 84 studies on the registry; 19 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.
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Drug: Givosiran · Drug: 5-probe cocktail
single dose of givosiran by subcutaneous (sc) injection
includes midazolam, caffeine, losartan, omeprazole, and dextromethorphan
Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail
Area under the concentration-time curve (AUC)
Time frame: Days 1 and 36
Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail
Maximum plasma concentration (Cmax)
Time frame: Days 1 and 36
Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail metabolites
Area under the concentration-time curve (AUC)
Time frame: Days 1 and 36
Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail metabolites
Maximum plasma concentration (Cmax)
Time frame: Days 1 and 36
Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail
Terminal half-life (t1/2)
Time frame: Days 1 and 36
Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail
Volume of distribution (V/F)
Time frame: Days 1 and 36
The pharmacodynamic (PD) effect of givosiran on urine levels of delta-aminolevulinic acid (ALA)
Time frame: Days 1, 8, and 36
The pharmacodynamic (PD) effect of givosiran on urine levels of Porphobilinogen (PBG) in patients with AIP
Time frame: Days 1, 8, and 36
Safety as evaluated by the proportion of subjects experiencing adverse events (AEs)
Time frame: Day 1 - Day 92
Plan to share: Undecided
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Givosiran