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

Sponsor

ATXA Therapeutics Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06092788

Collaborator

Hammersmith Medicines Research (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: NTP42:KVA4 Capsule Drug: NTP42:KVA4 Liquid	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hammersmith Medicines Research	London		United Kingdom	NW10 7EW

Sponsors and Collaborators

ATXA Therapeutics Limited
Hammersmith Medicines Research

Investigators

Principal Investigator: Takahiro Yamamoto, MD, Hammersmith Medicines Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ATXA Therapeutics Limited

ClinicalTrials.gov Identifier:

NCT06092788

Other Study ID Numbers:

ATXA-CT002

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 23, 2023