Clincosm LogoSign in Get a demo

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

Sponsor
Eidos Therapeutics, a BridgeBio company (Industry)
Overall Status
Completed
CT.gov ID
NCT04769479
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
5.2
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Tablet Formulations in Healthy Subjects
Actual Study Start Date :
Mar 28, 2021
Actual Primary Completion Date :
Aug 4, 2021
Actual Study Completion Date :
Sep 3, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: acoramidis

Drug: acoramidis
acoramidis
Other Names:
  • AG10

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic Assessments: Cmax [72 hours]

      Maximum Concentration (Cmax)

    2. Pharmacokinetic Assessments: AUC [72 hours]

      Area under the plasma concentration-time curve (AUC)

    3. Pharmacokinetic Assessments: Tmax [72 hours]

      Time to maximum concentration (Tmax)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Quotient Sciences Ruddington Nottingham United Kingdom NG11 6JS

    Sponsors and Collaborators

    • Eidos Therapeutics, a BridgeBio company

    Investigators

    • Principal Investigator: Philip Evans, MBChB, MRCS, Quotient Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eidos Therapeutics, a BridgeBio company
    ClinicalTrials.gov Identifier:
    NCT04769479
    Other Study ID Numbers:
    • AG10-006
    First Posted:
    Feb 24, 2021
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Amyloidosis

    Study Results

    No Results Posted as of Mar 23, 2022