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

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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 13
• 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: Adult
• Accepts Healthy Volunteers: Yes

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: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NTP42:KVA4 Capsule	Drug: NTP42:KVA4 Capsule; Single doses of NTP42:KVA4 administered to healthy volunteers as a capsule
Active Comparator: NTP42:KVA4 Oral Suspension	Drug: NTP42:KVA4 Liquid; Single doses of NTP42:KVA4 administered to healthy volunteers as a liquid

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ATXA Therapeutics Limited
• Collaborators: Hammersmith Medicines Research
• Investigators: Principal Investigator: Takahiro Yamamoto, MD, Hammersmith Medicines Research

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Actual): January 17, 2024
• Study Completion (Actual): January 17, 2024

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ATXA-CT002

Drug and device information, study documents

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