Status:
COMPLETED
A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects
Lead Sponsor:
Eidos Therapeutics, a BridgeBio company
Conditions:
Amyloidosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04769479
Start Date
March 28 2021
End Date
September 3 2021
Last Update
September 19 2024
Active Locations (1)
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1
Quotient Sciences
Ruddington, Nottingham, United Kingdom, NG11 6JS