HealthyPhase 1NCT06092788
Safety, Pharmacokinetics (PK) and Relative Bioavailability of NTP42:KVA4 as a Solid Oral Dose
A Phase 1 study testing NTP42:KVA4 Capsule and NTP42:KVA4 Liquid in people with Healthy, run by ATXA Therapeutics Limited at 1 site in United Kingdom.
Trial summary
This Phase 1 clinical trial will assess the safety, tolerability and pharmacokinetics (PK) of a solid capsule form of NTP42:KVA4 in male and female healthy volunteers. In a randomised, 3-way cross-over study, the Trial will involve 3 dose sessions where all volunteers will receive 3 single doses of NTP42:KVA4. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NTP42:KVA4 Capsule and NTP42:KVA4 Liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Nov 2023to 17 Jan 2024
- 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
- A body mass index (BMI) in the range 18.0-30.0
- Ability \& willingness to provide written consent
Who cannot join
- Clinically relevant abnormal medical history, physical findings, laboratory values at pre-trial screening.
- History of bleeding disorders, coagulation variables or abnormal blood cell count.
- History of chronic illness.
- Impaired endocrine, thyroid, hepatic, renal or respiratory function, diabetes mellitus, coronary heart disease or history of any psychotic mental illness.
- History of adverse reaction or allergy to any drug.
- Use of aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any other medicine that affects platelet function or coagulation, or any prescription medicine, during the 28 days before the first dose of trial medication.
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- History of drug or alcohol abuse
- Smoker or use of nicotine-containing products
- Blood pressure or heart rate at screening outside normal ranges.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Randomised, Open-label, 3-way Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics (With Food Effect), and Relative Bioavailability of NTP42:KVA4 Given as a Capsule, Compared With a Liquid, in Healthy Volunteers
This Phase 1 clinical trial will assess the safety, tolerability and pharmacokinetics (PK) of a solid capsule form of NTP42:KVA4 in male and female healthy volunteers. In a randomised, 3-way cross-over study, the Trial will involve 3 dose sessions where all volunteers will receive 3 single doses of NTP42:KVA4. In two of the dose sessions, volunteers will be fasted where, in one, they will be given the NTP42:KVA4 capsule and, in another, they will be given NTP42:KVA4 in oral liquid form. To test the effect of food on drug absorption (PK), the volunteers will also be given the NTP42:KVA4 capsule after eating a full breakfast.
- Conditions
- Healthy
- Being tested
- NTP42:KVA4 Capsule, NTP42:KVA4 Liquid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTP42:KVA4 CapsuleDrug
Single doses of NTP42:KVA4 administered to healthy volunteers as a capsule
NTP42:KVA4 LiquidDrug
Single doses of NTP42:KVA4 administered to healthy volunteers as a liquid
| Study group | Role | What they receive |
|---|---|---|
| NTP42:KVA4 Capsule | Experimental | Not described Receives: Drug: NTP42:KVA4 Capsule |
| NTP42:KVA4 Oral Suspension | Active comparator | Not described Receives: Drug: NTP42:KVA4 Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers
Adverse events (AEs)
Measured: Up to 48-hour post-dose
Evaluation of the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
Pharmacokinetic parameter: Area under the curve (AUC)
Measured: Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing
Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
Pharmacokinetic parameter: Area under the curve (AUC)
Measured: Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing
Secondary outcomes (1)
Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers
TXA2-induced platelet aggregometry
Measured: Predose, 2-, 6-, 24- & 48-hours post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start24 Nov 2023
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- ATXA Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Responsible party
- Sponsor
- Investigators
- Takahiro Yamamoto, MD, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092788
- Sponsor's protocol ID
- ATXA-CT002
- Status last verified
- Jul 2024
- First submitted
- 16 Oct 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomised, Open-label, 3-way Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics (With Food Effect), and Relative Bioavailability of NTP42:KVA4 Given as a Capsule, Compared With a Liquid, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06092788
- Acronym / sponsor ID
- ATXA-CT002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- ATXA Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 23 Oct 2023 (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 Phase 1 clinical trial will assess the safety, tolerability and pharmacokinetics (PK) of a solid capsule form of NTP42:KVA4 in male and female healthy volunteers. In a randomised, 3-way cross-over study, the Trial will involve 3 dose sessions where all volunteers will receive 3 single doses of NTP42:KVA4. In two of the dose sessions, volunteers will be fasted where, in one, they will be given the NTP42:KVA4 capsule and, in another, they will be given NTP42:KVA4 in oral liquid form. To test the effect of food on drug absorption (PK), the volunteers will also be given the NTP42:KVA4 capsule after eating a full breakfast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTP42:KVA4 Capsule | Experimental | Drug: NTP42:KVA4 Capsule |
| NTP42:KVA4 Oral Suspension | Active comparator | Drug: NTP42:KVA4 Liquid |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- A body mass index (BMI) in the range 18.0-30.0
- Ability \& willingness to provide written consent
Key exclusion criteria (9 listed)
- Clinically relevant abnormal medical history, physical findings, laboratory values at pre-trial screening.
- History of bleeding disorders, coagulation variables or abnormal blood cell count.
- History of chronic illness.
- Impaired endocrine, thyroid, hepatic, renal or respiratory function, diabetes mellitus, coronary heart disease or history of any psychotic mental illness.
- History of adverse reaction or allergy to any drug.
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 |
|---|---|---|
| NTP42:KVA4 CapsuleSingle doses of NTP42:KVA4 administered to healthy volunteers as a capsule | Drug | NTP42:KVA4 Capsule |
| NTP42:KVA4 LiquidSingle doses of NTP42:KVA4 administered to healthy volunteers as a liquid | Drug | NTP42:KVA4 Oral Suspension |
Primary outcome
Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers
Time frame: Up to 48-hour post-dose
Adverse events (AEs)
Evaluation of the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
Time frame: Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing
Pharmacokinetic parameter: Area under the curve (AUC)
Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
Time frame: Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing
Pharmacokinetic parameter: Area under the curve (AUC)
1 secondary outcome
Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers
Time frame: Predose, 2-, 6-, 24- & 48-hours post-dosing
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 22 Jul 2024.
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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.
Takahiro Yamamoto, MD principal investigator
Hammersmith Medicines Research
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 NTP42:KVA4 Capsule and NTP42:KVA4 Liquid in people with Healthy, run by ATXA Therapeutics Limited 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 2 inclusion and 9 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 22 Jul 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?
Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers (time frame: Up to 48-hour post-dose). 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 22 Jul 2024.