Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo

• Registration Number: NCT04919863
• Lead Sponsor: ATXA Therapeutics Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-20
• Study Start: 2021-05-24
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-09
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 79

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: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Evaluate the safety and tolerability of single and repeated doses of NTP42:KVA4 in healthy volunteers.	Up to 48-hour post-dose.	Adverse events (AEs)
Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 in healthy volunteers.	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 pharmacokinetics of single and repeated doses of NTP42:KVA4 in healthy volunteers.	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom