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

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ATXA Therapeutics Limited
• Collaborator: Hammersmith Medicines Research

Criteria

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.