Trial | NCT03294707  Report issue

Title

Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10
A Phase 1 Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study of the Tolerability, Pharmacokinetics and Pharmacodynamics of AG10 in Healthy Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    56
This is a single center, prospective, randomized, placebo-controlled study of AG10 in healthy adult subjects
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.
Study Started
Sep 11
2017
Primary Completion
Feb 05
2018
Study Completion
May 18
2018
Last Update
May 23
2018

Drug AG10 oral tablet

Active single ascending dose

  • Other names: Eidos Therapeutics AG10

Drug Placebo Oral Tablet

Placebo single dose

  • Other names: Matching placebo

AG10 single oral dose Experimental

AG10 oral tablet, administered by mouth, once

Placebo single oral dose Placebo Comparator

Placebo Oral Tablet, administered by mouth, once

Criteria 

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;
No Results Posted