Trials / Completed
CompletedNCT03505853
A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP)
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
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Alnylam Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Givosiran | single dose of givosiran by subcutaneous (sc) injection |
| DRUG | 5-probe cocktail | includes midazolam, caffeine, losartan, omeprazole, and dextromethorphan |
Timeline
- Start date
- 2018-04-26
- Primary completion
- 2018-11-16
- Completion
- 2019-01-10
- First posted
- 2018-04-23
- Last updated
- 2019-03-12
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT03505853. Inclusion in this directory is not an endorsement.