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

ATXA Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: NTP42:KVA4 Capsule

Drug: NTP42:KVA4 Liquid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06092788

ATXA-CT002

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.