Study to Assess the Effect of Food on a Single Dose of Acoramidis in Healthy Adult Participants

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT04958135
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Acoramidis — DRUG
    Film-coated immediate release oral tablet.

Study Details

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).

Key Dates

Start date
May 30, 2021
Status verified
Mar 2026
Primary completion
Aug 4, 2021
Completion
Aug 4, 2021

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Sequence 1: Acoramidis
    Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows: Period 1: Acoramidis as an immediate-release tablet under fasted conditions. Period 2: Acoramidis as an immediate-release tablet under fed conditions. There will be a washout period of at least 14 days between acoramidis dosing.
  • Experimental: Sequence 2: Acoramidis
    Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows: Period 1: Acoramidis as an immediate-release tablet under fed conditions. Period 2: Acoramidis as an immediate-release tablet under fasted conditions. There will be a washout period of at least 14 days between acoramidis dosing.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) Of Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions [ Time Frame: Up to 336 hours postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionLincolnNebraska68502-

Find similar trials in Lincoln, NE

By research site
Celerion· Lincoln, NE

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