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CompletedNCT04769479

A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects

A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Tablet Formulations in Healthy Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Eidos Therapeutics, a BridgeBio company · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

This is a single centre, open-label, 5-period study in healthy male and non-pregnant and non-lactating healthy female subjects.

Detailed description

It is planned to enroll 14 subjects who will receive single oral doses of active IMP in a sequential manner over 5 periods, with a minimum of 7days between dosing in each period.

Conditions

Interventions

TypeNameDescription
DRUGacoramidisacoramidis

Timeline

Start date
2021-03-28
Primary completion
2021-08-04
Completion
2021-09-03
First posted
2021-02-24
Last updated
2024-09-19

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04769479. Inclusion in this directory is not an endorsement.

A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects (NCT04769479) · Clinical Trials Directory