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Completed

NCT Number: NCT06092788

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NTP42:KVA4 Capsule

Drug

Single doses of NTP42:KVA4 administered to healthy volunteers as a capsule

NTP42:KVA4 Liquid

Drug

Single doses of NTP42:KVA4 administered to healthy volunteers as a liquid

Primary outcomes

  1. Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers

    Time frame: Up to 48-hour post-dose

    Adverse events (AEs)

  2. Evaluation of the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers

    Time frame: Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing

    Pharmacokinetic parameter: Area under the curve (AUC)

  3. Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers

    Time frame: Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing

    Pharmacokinetic parameter: Area under the curve (AUC)

Secondary outcomes

  1. Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers

    Time frame: Predose, 2-, 6-, 24- & 48-hours post-dosing

    TXA2-induced platelet aggregometry

Sponsors and collaborators

Lead sponsor

ATXA Therapeutics Limited

Industry

Collaborators

  • Hammersmith Medicines Research

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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