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

ATXA Therapeutics Limited13 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

NTP42:KVA4 Capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers

Adverse events (AEs)

Time frame: 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)

Time frame: 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)

Time frame: Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing

Secondary Outcomes

Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers

TXA2-induced platelet aggregometry

Time frame: Predose, 2-, 6-, 24- & 48-hours post-dosing