## Protocol Section
### Identification Module
**NCT ID:** NCT04769479

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

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

#### Organization Study ID Info
**ID:** AG10-006
#### Organization
**Class:** INDUSTRY
**Full Name:** Eidos Therapeutics, a BridgeBio company
### Status Module
#### Completion Date
**Date:** 2021-09-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-03-23

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-08-04

**Type:** ACTUAL

#### Start Date
**Date:** 2021-03-28

**Type:** ACTUAL

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2021-02-24
**Type:** ACTUAL
**Study First Submit Date:** 2021-02-19
**Study First Submit QC Date:** 2021-02-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Eidos Therapeutics, a BridgeBio company

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Amyloidosis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 14

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: acoramidis

**Label:** acoramidis

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- acoramidis

**Description:** acoramidis

**Name:** acoramidis

**Other Names:**

- AG10

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Maximum Concentration (Cmax)

**Measure:** Pharmacokinetic Assessments: Cmax

**Time Frame:** 72 hours

**Description:** Area under the plasma concentration-time curve (AUC)

**Measure:** Pharmacokinetic Assessments: AUC

**Time Frame:** 72 hours

**Description:** Time to maximum concentration (Tmax)

**Measure:** Pharmacokinetic Assessments: Tmax

**Time Frame:** 72 hours

### Eligibility Module

**Eligibility 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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ruddington

**Country:** United Kingdom

**Facility:** Quotient Sciences

**State:** Nottingham

**Zip:** NG11 6JS

#### Overall Officials

**Official 1:**

**Affiliation:** Quotient Sciences

**Name:** Philip Evans, MBChB, MRCS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000057165

- Term: Proteostasis Deficiencies

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4021

- Name: Amyloidosis

- Relevance: HIGH

- As Found: Amyloidosis

- ID: M28747

- Name: Proteostasis Deficiencies

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000686

- Term: Amyloidosis

### Misc Info Module

- Version Holder: 2024-05-24
