Trials / Completed
CompletedNCT04958135
Study to Assess the Effect of Food on a Single Dose of Acoramidis in Healthy Adult Participants
A Phase 1, Randomized, Open-Label, 2-Period, 2-Sequence, 2-Way Crossover Study to Assess the Effect of Food on the Single Dose Pharmacokinetics of Acoramidis in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the effect of a high-fat, high-caloric meal on the pharmacokinetics (PK) of acoramidis in healthy adult participants following an oral single dose administration of acoramidis. Blood sampling for PK assessment will include measures for acoramidis and its metabolite, acoramidis acyl glucuronide (acoramidis-AG).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acoramidis | Film-coated immediate release oral tablet. |
Timeline
- Start date
- 2021-05-30
- Primary completion
- 2021-08-04
- Completion
- 2021-08-04
- First posted
- 2021-07-12
- Last updated
- 2026-03-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04958135. Inclusion in this directory is not an endorsement.