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

Phase 1

Completed

• Conditions: Amyloidosis
• Interventions: Drug: acoramidis

• Registration Number: NCT04769479
• Lead Sponsor: Eidos Therapeutics, a BridgeBio company

Brief 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.

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-24
• Study Start: 2021-03-28
• Primary Completion: 2021-08-04
• Study Completion: 2021-09-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
acoramidis	acoramidis	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Assessments: Cmax	72 hours	Maximum Concentration (Cmax)
Pharmacokinetic Assessments: AUC	72 hours	Area under the plasma concentration-time curve (AUC)
Pharmacokinetic Assessments: Tmax	72 hours	Time to maximum concentration (Tmax)

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Ruddington, Nottingham, United Kingdom