Healthy VolunteersPhase 1NCT05476107
SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects
A Phase 1 study testing AMT-126 and Radioactive Tablet (Part 2 Only) in people with Healthy Volunteers, run by Applied Molecular Transport at 1 site in United Kingdom.
Trial summary
Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AMT-126 and Radioactive Tablet (Part 2 Only)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2021to 26 Mar 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects and female subjects of NOCBP.
- Between 18 and 55 years of age (Part 1) and 30 and 55 years of age (Part 2), inclusive.
- A body mass index of between 18.0 and 32.0 kg/m2, inclusive.
- Contraception requirements for male \& female subjects.
Who cannot join
- Known hypersensitivity or allergy to AMT-126 or excipient contained in the drug formulation.
- Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
- Presence, or history of clinically significant disease which requires treatment, as judged by the investigator.
- Evidence of current SARS-CoV-2 or COVID infection.
- Women of child-bearing potential.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects
Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126
Read the detailed description
A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects
- Conditions
- Healthy Volunteers
- Being tested
- AMT-126, Placebo, Radioactive Tablet (Part 2 Only)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT-126Drug
Also called no other name applicable
Single or daily dosing at doses A, B, C, D, E, F; G, H, and I
PlaceboDrug
Also called no other name applicable
Single or daily dosing at doses A, B, C, D, E, F; G,H, and I
Radioactive Tablet (Part 2 Only)Other
Also called no other name applicable
Single dose in two periods in Part 2 (optional)
| Study group | Role | What they receive |
|---|---|---|
| AMT-126 | Experimental | oral AMT-126 Receives: Drug: AMT-126 |
| Placebo | Placebo comparator | oral placebo Receives: Drug: Placebo |
| Radioactive Tablet (Part 2 only) | Other | oral radioactive tablet for scintigraphic analysis Receives: Other: Radioactive Tablet (Part 2 Only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent adverse events (safety and tolerability)
Single ascending doses of AMT-126 in healthy adult volunteers by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v5.0
Measured: 5 days
To assess the in vivo performance of an AMT-126 tablet formulation (Optional, Part 2 only)
Qualitative scintigraphic data will be compiled using the following data points for analysis: tablet release (hh:mm), location of tablet release (anatomical location), gastric emptying and arrival times (hh:mm)
Measured: 5 days
Secondary outcomes (1)
To assess pharmacokinetics of AMT-126 in healthy volunteers
Assess PK parameters (i.e. Cmax) as applicable for AMT-126
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start26 Feb 2021
- Primary completion26 Mar 2022
- Study completion26 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Study participants will be randomized to either receive AMT-126 or placebo (Part 1), Radiolabeled tablet (Part 2)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Molecular Transport
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476107
- Sponsor's protocol ID
- AMT-126-001
- Other IDs
- 2020-005779-11
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT05476107
- Acronym / sponsor ID
- AMT-126-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Applied Molecular TransportIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 26 Mar 2022 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 27 Jul 2022 (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.
Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126
Detailed description
A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Study participants will be randomized to either receive AMT-126 or placebo (Part 1), Radiolabeled tablet (Part 2)
| Arm | Type | Receives |
|---|---|---|
| AMT-126 | Experimental | Drug: AMT-126oral AMT-126 |
| Placebo | Placebo comparator | Drug: Placebooral placebo |
| Radioactive Tablet (Part 2 only) | Other | Other: Radioactive Tablet (Part 2 Only)oral radioactive tablet for scintigraphic analysis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects and female subjects of NOCBP.
- Between 18 and 55 years of age (Part 1) and 30 and 55 years of age (Part 2), inclusive.
- A body mass index of between 18.0 and 32.0 kg/m2, inclusive.
- Contraception requirements for male \& female subjects.
Key exclusion criteria (5 listed)
- Known hypersensitivity or allergy to AMT-126 or excipient contained in the drug formulation.
- Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
- Presence, or history of clinically significant disease which requires treatment, as judged by the investigator.
- Evidence of current SARS-CoV-2 or COVID infection.
- Women of child-bearing potential.
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 |
|---|---|---|
| AMT-126Also: no other name applicableSingle or daily dosing at doses A, B, C, D, E, F; G, H, and I | Drug | AMT-126 |
| PlaceboAlso: no other name applicableSingle or daily dosing at doses A, B, C, D, E, F; G,H, and I | Drug | Placebo |
| Radioactive Tablet (Part 2 Only)Also: no other name applicableSingle dose in two periods in Part 2 (optional) | Other | Radioactive Tablet (Part 2 only) |
Primary outcome
Incidence of Treatment-emergent adverse events (safety and tolerability)
Time frame: 5 days
Single ascending doses of AMT-126 in healthy adult volunteers by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v5.0
To assess the in vivo performance of an AMT-126 tablet formulation (Optional, Part 2 only)
Time frame: 5 days
Qualitative scintigraphic data will be compiled using the following data points for analysis: tablet release (hh:mm), location of tablet release (anatomical location), gastric emptying and arrival times (hh:mm)
1 secondary outcome
To assess pharmacokinetics of AMT-126 in healthy volunteers
Time frame: 5 days
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 27 Jul 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 AMT-126 and Radioactive Tablet (Part 2 Only) in people with Healthy Volunteers, run by Applied Molecular Transport 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 4 inclusion and 5 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 27 Jul 2022. 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. Some participants in this study may receive a placebo. 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?
Incidence of Treatment-emergent adverse events (safety and tolerability) (time frame: 5 days). The study lists 2 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 27 Jul 2022.