Safety, Tolerability and Pharmacokinetics of NTP42:KVA4
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|ClinicalTrials.gov Identifier: NCT04919863|
Recruitment Status : Completed
First Posted : June 9, 2021
Last Update Posted : February 24, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: NTP42:KVA4 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||May 24, 2021|
|Actual Primary Completion Date :||January 20, 2022|
|Actual Study Completion Date :||January 20, 2022|
Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension.
|Placebo Comparator: Placebo||
Placebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution.
- 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)
- Evaluation of the pharmacodynamics effects of NTP42:KVA4 in healthy volunteers. [ Time Frame: Predose, 0.75, 2, 4, 8, 12 & 24 hours post-dosing ]TXA2-induced platelet aggregometry
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- A body mass index (BMI) in the range 18.0-30.0.
- Ability & willingness to provide written consent.
- 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.
- History of drug or alcohol abuse
- Smoker or use of nicotine-containing products
- Blood pressure or heart rate at screening outside normal ranges.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04919863
|Hammersmith Medicines Research|
|London, United Kingdom, NW10 7EW|
|Principal Investigator:||Malcolm Boyce, MD||Hammersmith Medicines Reserach|
|Responsible Party:||ATXA Therapeutics Limited|
|Other Study ID Numbers:||
|First Posted:||June 9, 2021 Key Record Dates|
|Last Update Posted:||February 24, 2022|
|Last Verified:||February 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|