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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)

NCT03505853 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-03-12

No results posted yet for this study

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.

Conditions

  • Acute Intermittent Porphyria (AIP)
  • Acute Hepatic Porphyria (AHP)
  • Porphyria, Acute Intermittent
  • Acute Porphyria

Interventions

DRUG

Givosiran

single dose of givosiran by subcutaneous (sc) injection

DRUG

5-probe cocktail

includes midazolam, caffeine, losartan, omeprazole, and dextromethorphan

Sponsors & Collaborators

Principal Investigators

  • Nader Najafian, MD · Alnylam Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2018-11-16
Completion
2019-01-10

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03505853 on ClinicalTrials.gov