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

Eidos Therapeutics

Status and phase

Completed

Phase 1

Conditions

Amyloidosis

Treatments

Drug: acoramidis

Study type

Interventional

Funder types

Industry

Identifiers

NCT04769479

AG10-006

Details and patient eligibility

About

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

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males or non-pregnant, non-lactating healthy females
Body mass index (BMI) of 18.0 to 32.0kg/m² and a body weight>50kg as measured at screening
Must be willing and able to communicate and participate in the whole study
Must provide written informed consent
Must agree to adhere to the contraception requirements

Exclusion criteria

Subjects who have received any IMP formulation in a clinical research study within the 90 days prior to Period 1, Day 1
History of any drug or alcohol abuse in the past 2 years
Subjects with pregnant or lactating partners
Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are allowed.
History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4g of paracetamol per day or HRT/hormonal contraception) in the 14 days before first IMP administration.