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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04769479

Enrollment

Registered

2021-02-24

Start date

2021-03-28

Completion date

2021-09-03

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis

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.

Interventions

DRUGacoramidis

acoramidis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026