A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP)

• Status: Completed
• Trial end date: 2019-01-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alnylam Pharmaceuticals
• Treatments: Dextromethorphan; Omeprazole

Criteria

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