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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06092788
• Other study ID #: ATXA-CT002
• Status: Recruiting
• Phase: Phase 1
• Start date: November 24, 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: ATXA Therapeutics Limited
• Contact: Switchboard
• Phone: +44(0) 20 8961 4130
• Email: HMR[@]hmrlondon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 2024
• Est. primary completion date: January 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• NTP42:KVA4 Capsule
Single doses of NTP42:KVA4 administered to healthy volunteers as a capsule
• NTP42:KVA4 Liquid
Single doses of NTP42:KVA4 administered to healthy volunteers as a liquid

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (2)

Lead Sponsor	Collaborator
ATXA Therapeutics Limited	Hammersmith Medicines Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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