Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2018-05-18

Brief Summary

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This is a single center, prospective, randomized, placebo-controlled study of AG10 in healthy adult subjects

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Detailed Description

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Up to 48 healthy volunteers will be given a single dose of AG10 or placebo and be monitored for safety and tolerability over a 5-day period. Up to 48 healthy volunteers will be given multiple doses of AG10 or placebo and be monitored for safety and tolerability over a 15-day period.

Conditions

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Amyloid Cardiomyopathy, Transthyretin-Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Subjects will be randomized with an overall ratio of 3:1 to AG10: placebo within each cohort

Study Groups

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AG10 single oral dose

AG10 oral tablet, administered by mouth, once

Group Type EXPERIMENTAL

AG10 oral tablet

Intervention Type DRUG

Active single ascending dose

Placebo single oral dose

Placebo Oral Tablet, administered by mouth, once

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo single dose

Interventions

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AG10 oral tablet

Active single ascending dose

Intervention Type DRUG

Placebo Oral Tablet

Placebo single dose

Intervention Type DRUG

Other Intervention Names

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Eidos Therapeutics AG10 Matching placebo

Eligibility Criteria

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Inclusion Criteria

* Weight between \>50 kg and ≤110 kg;
* BMI of 18 to 32 kg/m2;
* Subjects who are healthy as determined by medical history, physical examination, 12 lead ECG and standard laboratory tests;
* Subjects who are negative for drugs of abuse and alcohol tests;
* Subjects who are non-smokers;

Exclusion Criteria

* Subjects who have used prescription drugs within 4 weeks of first dosing;
* Subjects who have a prior cholecystectomy;
* Subjects who have used any over-the-counter medications within 7 days prior to Day -1;
* Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders;
* Subjects who have an abnormal screening ECG;

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes