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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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Trial Profile

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)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Givosiran (Primary) ; Caffeine; Dextromethorphan; Losartan; Midazolam; Omeprazole
  • Indications Acute intermittent porphyria
  • Focus Pharmacokinetics
  • Sponsors Alnylam Pharmaceuticals

Most Recent Events

  • 12 Sep 2021 Results effect of givosiran on the activity of five major CYP enzymes, that together metabolize approximately 80% of clinically used drugs (19), in subjects with AIP who have biochemically active disease but do not experience acute attacks, published in the Clinical Pharmacology and Therapeutics.
  • 14 Aug 2019 According to an Alnylam Pharmaceuticals media release, results from this study will be presented at the 2019 International Congress on Porphyrins and Porphyria (ICPP).
  • 05 Feb 2019 Status changed from active, no longer recruiting to completed.

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