Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NTP42:KVA4 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: NTP42:KVA4
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A body mass index (BMI) in the range 18.0-30.0. Ability & willingness to provide written consent. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NTP42:KVA4<br> | Drug: NTP42:KVA4<br>* Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of single and repeated doses of NTP42:KVA4 in healthy volunteers. | Adverse events (AEs) | 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) | 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) | Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the pharmacodynamics effects of NTP42:KVA4 in healthy volunteers. | TXA2-induced platelet aggregometry | Predose, 0.75, 2, 4, 8, 12 & 24 hours post-dosing |