HealthyPhase 1NCT04919863
Safety, Tolerability and Pharmacokinetics of NTP42:KVA4
A Phase 1 study testing NTP42:KVA4 in people with Healthy, run by ATXA Therapeutics Limited at 1 site in United Kingdom.
Trial summary
A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial. The trial will involve of 2 phases, a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NTP42:KVA4
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2021to 20 Jan 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
- Men only
- 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: A Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NTP42:KVA4 in Healthy Volunteers
A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial. The trial will involve of 2 phases, a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD phase will incorporate a food effect arm.
- Conditions
- Healthy
- Being tested
- NTP42:KVA4, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTP42:KVA4Drug
Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension.
PlaceboDrug
Placebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution.
| Study group | Role | What they receive |
|---|---|---|
| NTP42:KVA4 | Experimental | Not described Receives: Drug: NTP42:KVA4 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of single and repeated doses of NTP42:KVA4 in healthy volunteers.
Adverse events (AEs)
Measured: Up to 48-hour post-dose.
Evaluation of the pharmacokinetics of single and repeated doses of NTP42:KVA4 in healthy volunteers.
Pharmacokinetic parameter: Area under the Curve (AUC)
Measured: Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing.
Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 in healthy volunteers.
Pharmacokinetic parameter: Area under the Curve (AUC)
Measured: Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing.
Secondary outcomes (1)
Evaluation of the pharmacodynamics effects of NTP42:KVA4 in healthy volunteers.
TXA2-induced platelet aggregometry
Measured: Predose, 0.75, 2, 4, 8, 12 & 24 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 posted9 Jun 2021
- Study start24 May 2021
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- ATXA Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Responsible party
- Sponsor
- Investigators
- Malcolm Boyce, MD, Principal investigator, Hammersmith Medicines Reserach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919863
- Sponsor's protocol ID
- ATXA-CT001
- Status last verified
- Feb 2022
- First submitted
- 20 May 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reid HM, Maginn M, Perkins CM, Mulvaney EP, Boyce M, Yamamoto T, Kinsella BT. Evaluation of NTP42, a novel thromboxane receptor antagonist, in a first-in-human phase I clinical trial. Front Pharmacol. 2023 Dec 21;14:1296188. doi: 10.3389/fphar.2023.1296188. eCollection 2023.
PubMed 38178863
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NTP42:KVA4 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04919863
- Acronym / sponsor ID
- ATXA-CT001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- ATXA Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Study start
- 24 May 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 9 Jun 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.
A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial. The trial will involve of 2 phases, a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD phase will incorporate a food effect arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTP42:KVA4 | Experimental | Drug: NTP42:KVA4 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- 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:KVA4Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension. | Drug | NTP42:KVA4 |
| PlaceboPlacebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution. | Drug | Placebo |
Primary outcome
Evaluate the safety and tolerability of single and repeated doses of NTP42:KVA4 in healthy volunteers.
Time frame: Up to 48-hour post-dose.
Adverse events (AEs)
Evaluation of the pharmacokinetics of single and repeated doses of NTP42:KVA4 in healthy volunteers.
Time frame: Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing.
Pharmacokinetic parameter: Area under the Curve (AUC)
Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 in healthy volunteers.
Time frame: Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing.
Pharmacokinetic parameter: Area under the Curve (AUC)
1 secondary outcome
Evaluation of the pharmacodynamics effects of NTP42:KVA4 in healthy volunteers.
Time frame: Predose, 0.75, 2, 4, 8, 12 & 24 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 24 Feb 2022.
- Derived from this study: PubMed 38178863Reid HM, Maginn M, Perkins CM, Mulvaney EP, Boyce M, Yamamoto T, Kinsella BT. Evaluation of NTP42, a novel thromboxane receptor antagonist, in a first-in-human phase I clinical trial. Front Pharmacol. 2023 Dec 21;14:1296188. doi: 10.3389/fphar.2023.1296188. eCollection 2023.
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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.
Malcolm Boyce, MD principal investigator
Hammersmith Medicines Reserach
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 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 24 Feb 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?
Evaluate the safety and tolerability of single and repeated doses of NTP42:KVA4 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?
On the ClinicalTrials.gov record for NCT04919863, which also lists 1 linked publication.
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 24 Feb 2022.