A Phase 1 interventional study of AG10 oral tablet and Placebo Oral Tablet in Amyloid Cardiomyopathy, Transthyretin-Related, sponsored by Eidos Therapeutics, a BridgeBio company. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Eidos Therapeutics, a BridgeBio company (part of BridgeBio) · Phase 1, Interventional, and Treatment
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Among 58 studies in Amyloid Neuropathies, Familial with a site in United States — 23 open to participants now, 26 under way, 4 of them phase 3. Amyloid Neuropathies, Familial · United States.
Among the 58 studies in Amyloid Neuropathies, Familial with a site in United States, this one is the 19th largest by enrollment of the 38 interventional ones that give a count, is one of 2 that started in 2017, is one of 5 in phase 1, and was the 15th registered.
188 studies on the registry are indexed under Amyloid Neuropathies, Familial; 94 are open to participants now.
Browse Amyloid Neuropathies, Familial studies →23 of the 58 studies in Amyloid Neuropathies, Familial with a site in United States are open now. Recruiting first, the newest first:
Brigham and Women's Hospital · Sites in United States
Ages 18+
Eidos Therapeutics, a BridgeBio company · Sites in United States
Ages 18–80
Mayo Clinic · Sites in United States
Ages 18+
University of Texas Southwestern Medical Center · Sites in United States
Ages 30–80
University of Minnesota · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 69 Amyloid Neuropathies, Familial studies recruiting now, 53 (77%) set no upper age limit and 1 (1%) stops at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 7 · Phase 3 17 · Phase 4 6
First in 2006; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 56 is close to the median of 54 across 90 interventional studies indexed under Amyloid Neuropathies, Familial.
Median enrollment 53 across the 38 interventional studies, 125 across the 20 observational. Of the 29 that completed or were terminated, 17 (59%) have results posted.
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22 of 58 have an industry lead sponsor. The 10 most frequent:
This study is registered under Eidos Therapeutics, a BridgeBio company, one of the names counted as BridgeBio. Under that name alone:
Eidos Therapeutics, a BridgeBio company is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
BridgeBio has 9 studies filed under Amyloid Neuropathies, Familial — fewer than ten, so there is no comparison to draw.
11 of the studies in Amyloid Neuropathies, Familial with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05619302Phase 3Brigham and Women's HospitalMolecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis | 2026-12-31 |
| NCT07560306Phase 3Brigham and Women's Hospital[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy | 2027-03-30 |
| NCT07196839University of Texas Southwestern Medical CenterDetermining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study | 2026-12 |
| NCT07583823University of MinnesotaElevated Rate Pacing of Cardiac Amyloidosis | 2026-12-04 |
| NCT07062848Yale UniversityAn Observational Study Using Artificial Intelligence (AI) Algorithms on Electrocardiography (ECG), Point-of-care Ultrasound (POCUS), and Transthoracic Echocardiophy (TTE) to Estimate the Under-diagnosis of Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Across a Diverse Range of US Health Systems. | 2027-01 |
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Among the 58 studies in Amyloid Neuropathies, Familial with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AG10 oral tablet, administered by mouth, once
Drug: AG10 oral tablet
Placebo Oral Tablet, administered by mouth, once
Drug: Placebo Oral Tablet
Active single ascending dose
Also known as: Eidos Therapeutics AG10
Placebo single dose
Also known as: Matching placebo
Safety & tolerability: individual and summary blood pressures, heart rate, ECG and lab data presented in tabular form with descriptive statistics. Adverse events will be tabulated and summarized by Part A (SAD) vs. B (MAD), and treatment.
To evaluate the safety and tolerability of single and multiple doses of AG10 administered to healthy adult subjects
Time frame: 30 days
Pharmacokinetic Assessments: T1/2
Plasma half-life (t1/2)
Time frame: 30 days
Pharmacokinetic Assessments: Tmax
Time to maximum concentration (Tmax)
Time frame: 30 days
Pharmacokinetic Assessments: Cmax
Maximum concentration (Cmax)
Time frame: 30 days
Pharmacokinetic Assessments: Cmin
Cmin
Time frame: 30 days
Pharmacokinetic Assessments: AUC
Area under the plasma concentration-time curve (AUC)
Time frame: 30 days
Pharmacokinetic Assessments: Clearance
Apparent clearance (CL/F)
Time frame: 30 days
Pharmacokinetic Assessments: volume of distribution
Apparent volume of distribution (Vss/F)
Time frame: 30 days
Pharmacodynamic Assessments: Assessments of TTR stabilization will be listed and summarized by part, treatment, and time point using appropriate descriptive statistics.
AG10 binding to and/or stabilization of TTR will be evaluated by established ex vivo assays, including Fluorescent Polarization Exclusion Assay (FPE) and Immunoblotting (Western Blot) and quantitation of prealbumin (TTR).
Time frame: 30 days
Pharmacodynamic Assessments: Western blot
AG10 binding to and/or stabilization of TTR will be evaluated by established ex vivo assays: Immunoblotting (Western Blot)
Time frame: 30 days
Pharmacodynamic Assessments: prealbumin
AG10 binding to and/or stabilization of TTR will be evaluated by established ex vivo assays: quantitation of prealbumin (TTR).
Time frame: 30 days
Food effect: AUC
To evaluate the effect of food on the PK of AG10. The log transformed values of total AUC will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.
Time frame: 30 days
Food effect: Cmax
To evaluate the effect of food on the PK of AG10. The log transformed values of Cmax will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Feb 2018, 4 months.
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acoramidis
Amyloid Neuropathies, Familial →
Eidos Therapeutics, a BridgeBio company →