Safety, Pharmacokinetics (PK) and Relative Bioavailability of NTP42:KVA4 as a Solid Oral Dose

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: NTP42:KVA4 Capsule
* Drug: NTP42:KVA4 Liquid


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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All

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NTP42:KVA4 Capsule<br> | Drug: NTP42:KVA4 Capsule<br>* Single doses of NTP42:KVA4 administered to healthy volunteers as a capsule<br>|
| Active Comparator: NTP42:KVA4 Oral Suspension<br> | Drug: NTP42:KVA4 Liquid<br>* Single doses of NTP42:KVA4 administered to healthy volunteers as a liquid<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 NTP42:KVA4 when given as a capsule in healthy volunteers | Adverse events (AEs) | 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) | 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) | Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers | TXA2-induced platelet aggregometry | Predose, 2-, 6-, 24- & 48-hours post-dosing |