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

• Status: Recruiting
• Trial end date: 2021-09-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eidos Therapeutics; Eidos Therapeutics, a BridgeBio company

Criteria

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.