Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: NTP42:KVA4; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • Hammersmith Medicines Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ATXA Therapeutics Limited
• Collaborators: Hammersmith Medicines Research
• Investigators: Principal Investigator: Malcolm Boyce, MD, Hammersmith Medicines Reserach

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): January 20, 2022
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ATXA-CT001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No