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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT06092788
• Lead Sponsor: ATXA Therapeutics Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-23
• Study Start: 2023-11-24
• Primary Completion: 2024-01-17
• Study Completion: 2024-01-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers	Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing	Pharmacokinetic parameter: Area under the curve (AUC)
Evaluation of the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers	Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing	Pharmacokinetic parameter: Area under the curve (AUC)
Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers	Up to 48-hour post-dose	Adverse events (AEs)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom