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

Brief Title

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

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)

Brief 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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail

Secondary Outcome

 Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail metabolites

Condition

Acute Intermittent Porphyria (AIP)

Intervention

Givosiran

Study Arms / Comparison Groups

 Givosiran with 5-probe cocktail
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

April 26, 2018

Completion Date

January 10, 2019

Primary Completion Date

November 16, 2018

Eligibility 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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Nader Najafian, MD, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT03505853

Organization ID

ALN-AS1-004


Responsible Party

Sponsor

Study Sponsor

Alnylam Pharmaceuticals


Study Sponsor

Nader Najafian, MD, Study Director, Alnylam Pharmaceuticals


Verification Date

March 2019