AmyloidosisPhase 1NCT04769479
A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects
A Phase 1 study testing acoramidis in people with Amyloidosis, run by Eidos Therapeutics, a BridgeBio company at 1 site in United Kingdom.
Trial summary
This is a single centre, open-label, 5-period study in healthy male and non-pregnant and non-lactating healthy female subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyloidosis
- What is being tested?
- acoramidis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2021to 3 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Tablet Formulations in Healthy Subjects
This is a single centre, open-label, 5-period study in healthy male and non-pregnant and non-lactating healthy female subjects.
Read the 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
- Amyloidosis
- Being tested
- acoramidis
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acoramidisDrug
Also called AG10
acoramidis
| Study group | Role | What they receive |
|---|---|---|
| acoramidis | Experimental | Not described Receives: Drug: acoramidis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Assessments: Cmax
Maximum Concentration (Cmax)
Measured: 72 hours
Pharmacokinetic Assessments: AUC
Area under the plasma concentration-time curve (AUC)
Measured: 72 hours
Pharmacokinetic Assessments: Tmax
Time to maximum concentration (Tmax)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start28 Mar 2021
- Primary completion4 Aug 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eidos Therapeutics, a BridgeBio company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Evans, MBChB, MRCS, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769479
- Sponsor's protocol ID
- AG10-006
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Tablet Formulations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04769479
- Acronym / sponsor ID
- AG10-006
- Conditions
- Amyloidosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Eidos Therapeutics, a BridgeBio companyIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2021 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acoramidis | Experimental | Drug: acoramidis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acoramidisAlso: AG10acoramidis | Drug | acoramidis |
Primary outcome
Pharmacokinetic Assessments: Cmax
Time frame: 72 hours
Maximum Concentration (Cmax)
Pharmacokinetic Assessments: AUC
Time frame: 72 hours
Area under the plasma concentration-time curve (AUC)
Pharmacokinetic Assessments: Tmax
Time frame: 72 hours
Time to maximum concentration (Tmax)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Evans, MBChB, MRCS principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing acoramidis in people with Amyloidosis, run by Eidos Therapeutics, a BridgeBio company at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Assessments: Cmax (time frame: 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.