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

Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769479
• Other study ID #: AG10-006
• Status: Completed
• Phase: Phase 1
• Start date: March 28, 2021
• Est. completion date: September 3, 2021

Study information

• Verified date: March 2022
• Source: Eidos Therapeutics, a BridgeBio company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 3, 2021
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amyloidosis

Intervention

Drug:
• acoramidis
acoramidis

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Eidos Therapeutics, a BridgeBio company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Assessments: Cmax	Maximum Concentration (Cmax)	72 hours
Primary	Pharmacokinetic Assessments: AUC	Area under the plasma concentration-time curve (AUC)	72 hours
Primary	Pharmacokinetic Assessments: Tmax	Time to maximum concentration (Tmax)	72 hours